BITTOL ANTI-BACTERIAL LIQUID- benzalkonium chloride liquid Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited SirketiDisclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if theycomply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Bittol Anti-Bacterial Liquid Soap

Drug Facts

Active IngredientsBenzalkonium Chloride 0.13%

PurposeAntibacterial

UsesFor handwashing to decrease bacteria on the skin.

WARNINGSFor external use only.

When us ing this product:Do not use in or near the eyes. In case of eye contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if:Irritation and redness develops and last more than 72 hours.

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.(1-800-222-1222)

Directions:The pump to get some up Bittol Antibacterial Liquid Soap on your hand,lather it and wash your handswith very will.

Inactive Ingredients :Aqua/Water, Lauramine Oxide, PEG-150 Distearate, Cetrimonium Chloride, Myristamine Oxide, Coco-Glucoside, Glyceryl Oleate, Glycerin, Parfum/Fragrance, Disodium EDTA, Sodium Chloride, CitricAcid, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow 5.

Package Labeling:250ml

Package Labeling:500ml

Package Labeling:1000ml

BITTOL ANTI-BACTERIAL LIQUID benzalkonium chloride liquid

Product Information

Taha Kimya Kozmetik Ve Tuketim Urunleri Sanayi Pazarlama Limited Sirketi

Product T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:78 56 4-0 0 2

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -UNII:7N6 JUD5X6 Y)

BENZALKONIUMCHLORIDE

1.3 mg in 1 mL

Inactive IngredientsIngredient Name Strength

WATER (UNII: 0 59 QF0 KO0 R)

LAURAMINE O XIDE (UNII: 4F6 FC4MI8 W)

PEG-150 DISTEARATE (UNII: 6 F36 Q0 I0 AC)

CETRIMO NIUM CHLO RIDE (UNII: UC9 PE9 5IBP)

MYRISTAMINE O XIDE (UNII: J0 8 6 PM3RRT)

CO CO GLUCO SIDE (UNII: ICS79 0 225B)

GLYCERYL O LEATE (UNII: 4PC0 54V79 P)

GLYCERIN (UNII: PDC6 A3C0 OX)

EDETATE DISO DIUM ANHYDRO US (UNII: 8 NLQ36 F6 MM)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)

METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)

METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:78 56 4-0 0 2-0 1 250 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 9 /20 /20 20

2 NDC:78 56 4-0 0 2-0 2 50 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 9 /20 /20 20

3 NDC:78 56 4-0 0 2-0 3 10 0 0 mL in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 9 /20 /20 20

Marketing InformationMarke ting Cate gory Application Numbe r or Monograph Citation Marke ting Start Date Marke ting End Date

OTC mo no graph no t fina l part333E 0 9 /20 /20 20

Labeler - T aha Kimya Kozmetik Ve T uketim Urunleri Sanayi Pazarlama Limited Sirketi (565657236)

Revised: 9/2020