Download - COLGATE-PALMOLIVE (THAILAND) Limited,
WELLSTAR AMENITY- benzalkonium chloride and sodiummonofluorophosphate ASP Global, LLcDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they maybe marketed if they comply with applicable regulations and policies. FDA has notevaluated whether this product complies.
----------Wellstar Amenity KitInstant Hand AntisepticDrug Facts
Active IngredientEthyl Alcohol 62%
PurposeAntiseptic
UsesFor hand washing to decrease bacteria on the skin.Recommended for repeated use.
WarningsFlammable. Keep away from fire or flame.For external use only.Avoid contact with broken skin.When using this product do not use in or near the eyes. In case of contact, rinse eyesthoroughly with water.Stop use and ask a doctor if irritation or rash appears and lasts.Keep out of reach of children. If swallowed, get medical help.
DirectionsNot recommended for infants.Wet hands thoroughly with product and allow to dry without wiping.Children under 6 years of age should be supervised when using this product.
Other InformationDo not store above 110°F. May discolor some fabrics.
Inactive IngredientsWater, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer,Triethanolamine, Fragrance.Distributed by:ASP Global, LLC7800 Third Flag Parkway,Austell, GA 30168, USAColgate Anticavity ToothpasteDrug Facts
Active ingredientSodium monofluorophosphate 0.76% (0.15% w/v fluoride ion)
PurposeAnticavity
Usehelps protect against cavities
WarningsKeep out of the reach of children under 6 years of age.If more than used for brushing is accidentally swallowed, get medical help or contact aPoison Control Center right away.
Directions
adults and children2 years of age andolder
brush teeth thoroughly, preferablyafter each meal or at least twice aday, or as directed by a dentist orphysician
children 2 to 6years
use only a pea sized amount andsupervise child's brushing andrinsing (to minimize swallowing)
children under 2years ask a dentist or physician
®
Inactive ingredientsdicalcium phosphate dihydrate, water, sorbitol, sodium lauryl sulfate, flavor, cellulosegum, tetrasodium pyrophosphate, sodium saccharin
Questions or comments?Call toll-free 1-800-468-6502Manufactured by: COLGATE-PALMOLIVE (THAILAND) Limited, Chonburi 20000, Thailand.
PRINCIPAL DISPLAY PANEL - 53 mL Bottle LabelWellstarInstant Hand Antiseptic62% w/w Ethyl Alcohol1.9 FL OZ / 53 mLDistributed by:ASP Global, LLC7800 Third Flag Parkway,Austell, GA 30168, USARev 00
PRINCIPAL DISPLAY PANEL - 10 g Tube LabelP1505037Colgate Anticavity ToothpasteCavity ProtectionNET WT 10g7OTHER
®
PRINCIPAL DISPLAY PANEL - Kit LabelWellstarItem #: WSHKIT02Description: AMENITY KIT, WELLSTARPO #: Lot #: XMMDDFCExp: YYYY-MM-DDQty: 20 KIT/CSCarton #: XXX of XXXXNet Wt.: XX KGGross Wt.: XX KGCubic Dimensions: 65.0 x 20.0 x 33.0 CMAssembled in ChinaComponents Made in China:
Hand SanitizerAlcohol-Free MouthwashLip BalmToothbrushHairbrushBody LotionBody WashShampoo/ConditionerDeodorant Stick
Facial TissueNail FilePenNotepadKit Case
Component Made in Thailand:Toothpaste
WSHKIT02-MC-00WellstarContents/Origins:2.0 fl. oz. Shampoo/Conditioner2.0 fl. oz. Body Wash2.0 fl. oz. Body Lotion2.0 fl. oz. Alcohol-Free Mouthwash0.15 oz. net wt. Lip Balm0.5 oz. net wt. Deodorant Stick1.9 fl. oz. Hand SanitizerToothbrush, Hairbrush, Facial Tissue, Nail File, Pen, Notepad,and Kit Case: Made in ChinaToothpaste: Made in ThailandLot #: Exp:Distributed by: ASP Global, LLC 7800 Third Flag Parkway, Austell, GA 30168, USAREV 00Wellstar
WELLSTAR AMENITY benzalkonium chloride and sodium monofluorophosphate kit
Product InformationProduct Type HUMAN OTC DRUG Item Code (Source) NDC:59448-800
Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:59448-800-00 20 in 1 BOX 10/01/20211 1 in 1 BAG
Quantity of PartsPart # Package Quantity Total Product QuantityPart 1 1 BOTTLE, PLASTIC 53 mLPart 2 1 TUBE 10 gPart 3 1 TUBE 59 mLPart 4 1 TUBE 59 mLPart 5 1 TUBE 59 mLPart 6 1 TUBE 4.25 gPart 7 1 BOTTLE, PLASTIC 65 mLPart 8 1 BOTTLE, WITH APPLICATOR 14 g
Part 1 of 8INSTANT HAND ANTISEPTIC alcohol gel
Product InformationItem Code (Source) NDC:59448-008
Route of Administration TOPICAL
Active Ingredient/Active MoietyIngredient Name Basis of Strength Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M) Alcohol 62 mL in 100 mL
Inactive IngredientsIngredient Name Strength
Water (UNII: 059QF0KO0R) Aloe Vera Leaf (UNII: ZY81Z83H0X) Glycerin (UNII: PDC6A3C0OX) Propylene Glycol (UNII: 6DC9Q167V3) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) Trolamine (UNII: 9O3K93S3TK)
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:59448-
008-0153 mL in 1 BOTTLE, PLASTIC; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333E 10/01/2021
Part 2 of 8COLGATE ANTICAVITY sodium monofluorophosphate paste, dentifrice
Product InformationItem Code (Source) NDC:42555-060
Route of Administration DENTAL
Active Ingredient/Active MoietyIngredient Name Basis of
Strength Strength
Sodium Monofluorophosphate (UNII: C810JCZ56Q) (Fluoride Ion - Fluoride Ion 7.6 mg
UNII:Q80VPU408O) Fluoride Ion in 1 g
Inactive IngredientsIngredient Name Strength
Dibasic Calcium Phosphate Dihydrate (UNII: O7TSZ97GEP) Water (UNII: 059QF0KO0R) Sorbitol (UNII: 506T60A25R) Sodium Lauryl Sulfate (UNII: 368GB5141J) Sodium Pyrophosphate (UNII: O352864B8Z) Saccharin Sodium (UNII: SB8ZUX40TY)
Product CharacteristicsColor WHITE Score Shape SizeFlavor MINT Imprint CodeContains
Packaging# Item Code Package Description Marketing Start
DateMarketing End
Date1 NDC:42555-060-
4510 g in 1 TUBE; Type 0: Not a CombinationProduct
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph final part355 06/04/2009
Part 3 of 8GILCHRIST AND SOAMES BODY BUTTER--LOTION cleansing (cold creams, cleansing lotions, liquids, and pads)
Product Information
Other IngredientsIngredient
Kind Ingredient Name Quantity
INGR Water (UNII: 059QF0KO0R) INGR ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M) INGR CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) INGR CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) INGR ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) INGR BENZYL ALCOHOL (UNII: LKG8494WBH) INGR PEG-100 STEARATE (UNII: YD01N1999R)
INGR CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)(UNII: 4Q93RCW27E)
INGR DEHYDROACETIC ACID (UNII: 2KAG279R6R) INGR SODIUM HYDROXIDE (UNII: 55X04QC32I)
Product Characteristicscolor WHITE C48325
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 59 mL in 1 TUBE; Type 0: Not a CombinationProduct
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 07/01/2013
Part 4 of 8GILCHRIST AND SOAMES HAIR 2 IN 1--SHAMPOO-CONDITIONER shampoos (non-coloring)
Product Information
Other IngredientsIngredient
Kind Ingredient Name Quantity
INGR Water (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR COCO MONOETHANOLAMIDE (UNII: C80684146D)
INGR POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII:U1G23TFV1K)
INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR MAGNESIUM NITRATE (UNII: 77CBG3UN78) INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) INGR MAGNESIUM CHLORIDE (UNII: 02F3473H9O) INGR METHYLPARABEN (UNII: A2I8C7HI9T) INGR PROPYLPARABEN (UNII: Z8IX2SC1OH) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C RED NO. 4 (UNII: X3W0AM1JLX)
Product Characteristicscolor YELLOW C48330
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 59 mL in 1 TUBE; Type 0: Not a CombinationProduct
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 07/01/2013
Part 5 of 8GILCHRIST AND SOAMES BODY REFRESHER--BODY WASH skin fresheners
Product Information
Other IngredientsIngredient
Kind Ingredient Name Quantity
INGR Water (UNII: 059QF0KO0R) INGR SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0) INGR SODIUM CHLORIDE (UNII: 451W47IQ8X) INGR COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) INGR GLYCERIN (UNII: PDC6A3C0OX)
INGR POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 2600000 MW) (UNII:U1G23TFV1K)
INGR COCO MONOETHANOLAMIDE (UNII: C80684146D) INGR MAGNESIUM NITRATE (UNII: 77CBG3UN78) INGR CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
INGR METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) INGR MAGNESIUM CHLORIDE (UNII: 02F3473H9O) INGR METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) INGR FD&C YELLOW NO. 5 (UNII: I753WB2F1M) INGR FD&C RED NO. 4 (UNII: X3W0AM1JLX) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristicscolor WHITE C48325
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 59 mL in 1 TUBE; Type 0: Not a CombinationProduct
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 11/01/2016
Part 6 of 8WELLSTAR LIP BALM lipstick
Product Information
Other IngredientsIngredient Kind Ingredient Name Quantity
INGR ETHYLHEXYL PALMITATE (UNII: 2865993309) INGR MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) INGR POLYISOBUTYLENE (2300 MW) (UNII: DSQ2V1DD1K) INGR YELLOW WAX (UNII: 2ZA36H0S2V) INGR HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7) INGR SHEANUT OIL (UNII: O88E196QRF) INGR .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T)
Product Characteristicscolor YELLOW C48330
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 4.25 g in 1 TUBE; Type 0: Not a CombinationProduct
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 06/13/2018
Part 7 of 8ASP GLOBAL ALCOHOL-FREE MOUTHWASH mouthwashes and breath fresheners (liquids and sprays)
Product Information
Other IngredientsIngredient Kind Ingredient Name Quantity
INGR Water (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR POLYSORBATE 20 (UNII: 7T1F30V5YH) INGR SODIUM BENZOATE (UNII: OJ245FE5EU) INGR MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) INGR SACCHARIN SODIUM (UNII: SB8ZUX40TY) INGR CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) INGR FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
Product Characteristicscolor BLUE C48333flavor MINT C73404
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 65 mL in 1 BOTTLE, PLASTIC; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 06/13/2018
Part 8 of 8GILCHRIST AND SOAMES DEODORANT deodorants (underarm)
Product Information
Other IngredientsIngredient Kind Ingredient Name Quantity
INGR Water (UNII: 059QF0KO0R) INGR GLYCERIN (UNII: PDC6A3C0OX) INGR Polyethylene Glycol 400 (UNII: B697894SGQ) INGR Stearic Acid (UNII: 4ELV7Z65AP) INGR Polysorbate 20 (UNII: 7T1F30V5YH) INGR Sodium Hydroxide (UNII: 55X04QC32I) INGR WHITE WAX (UNII: 7G1J5DA97F) INGR Starch, Rice (UNII: 4DGK8B7I3S) INGR Lavender Oil (UNII: ZBP1YXW0H8) INGR Tannic Acid (UNII: 28F9E0DJY6) INGR Sodium Lactate (UNII: TU7HW0W0QT) INGR Butylene Glycol (UNII: 3XUS85K0RA) INGR PHENOXYETHANOL (UNII: HIE492ZZ3T) INGR Benzyl Alcohol (UNII: LKG8494WBH) INGR Coumarin (UNII: A4VZ22K1WT) INGR LINALOOL, (+/-)- (UNII: D81QY6I88E) INGR LIMONENE, (+)- (UNII: GFD7C86Q1W)
Packaging# Item
Code Package Description Marketing StartDate
Marketing EndDate
1 14 g in 1 BOTTLE, WITH APPLICATOR; Type 0: Not aCombination Product
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
Cosmetic 10/24/2018
ASP Global, LLc
Marketing InformationMarketingCategory
Application Number or MonographCitation
Marketing StartDate
Marketing EndDate
OTC monograph notfinal part333E 10/01/2021
Labeler - ASP Global, LLc (080361159)
EstablishmentName Address ID/FEI Business Operations
Shengzhou Kingbird Travel Products Co.,Ltd. 560219293 PACK(59448-800) , LABEL(59448-800) ,
REPACK(59448-800)
EstablishmentName Address ID/FEI Business Operations
Colgate-Palmolive (Thailand) LTD 672044552 MANUFACTURE(59448-800)
EstablishmentName Address ID/FEI Business Operations
Nantong Health & Beyond Hygienic Products Inc. 421280161 MANUFACTURE(59448-800)
Revised: 10/2021