LIGHTNING PAIN RELIEF- menthol cream Clinical Resolution Laboratory, Inc.Disclaimer: 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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Lightning Pain Relief Cream

DRUG FACTS

Active Ingredients

Menthol 4%

Purpose

Cooling Pain Relief

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with arthritis,backache, strains and sprains.

Warnings

(For external use only)

Do not use this product iftamper-evident "Do not use this product" if safety seal is broken or missing. pregnant or breastfeeding, ask a health professional before use.

When us ing this productavoid contact with the eyes or mucous membranes do not use with other ointments, creams, sprays or linimentsdo not apply to irritated skin or if excessive irritation developsdo not apply to wounds or damaged skin do not use with heating pad or device do not bandage

Stop use and ask a doctor ifCondition worsens, or if symptoms persist more than 7 days, or clear up and reoccur.

Keep out of reach of childrenif swallowed, call your Poison Control Center at 1 (800) 222-1222.

Directionsadults and children 12 years of age and older: Apply liberally to the affected area(s) and continue tomassage in thoroughly for 1-2 minutes until it has been absorbed. For best results, apply 2-3 timesdaily or as needed.children under 12 years of age, consult a doctor.

Other Informationstore in room temperature (59~86°F)

Inactive Ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Aloe Barbadensis Leaf Juice Extract,Arnica Montana Flower Extract, Boswellia Serrata Extract, Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Camphor, Cannabis Sativa Seed Oil, Carbomer, Centella Asiatica Leaf Extract,Cholesterol, Dimethicone, Dimethyl Isosorbide Dipotassium Glycyrrhizate, Disodium EDTA, Emu Oil,Ethoxydiglycol, Eucalyptus Globulus Leaf Oil, Glycerin, Glyceryl Stearate, Helianthus Annuus(Sunflower) Seed Oil, Isopropyl Myristate, Laureth-7, Lavandula Angustifolia (Lavender) Oil, Lecithin,Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methyl Sulfonyl Methane (MSM), PEG-100 Stearate,Phenoxyethanol, Polyacrylamide, Polysorbate 20, Purified Water, Pyridoxine HCL (Vit. B6), SDAlcohol 40-B, Sodium Benzoate, Tocopheryl Acetate, Triethanolamine

Lightning Pain Relief Cream, 2.28 fl.oz/ 65g (63742-013-00)

Lightning Pain Relief Cream, 3.56 fl.oz/101g (63742-013-01)

LIGHTNING PAIN RELIEF menthol cream

Product InformationProduct T ype HUMAN OTC DRUG Ite m Code (Source ) NDC:6 3742-0 13

Route of Adminis tration TOPICAL

Active Ingredient/Active MoietyIngredient Name Basis o f Strength Strength

MENTHO L (UNII: L7T10 EIP3A) (MENTHOL - UNII:L7T10 EIP3A) MENTHOL 40 mg in 1 g

Inactive IngredientsIngredient Name Strength

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

ALLANTO IN (UNII: 344S277G0 Z)

ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)

Clinical Resolution Laboratory, Inc.

ARNICA MO NTANA FLO WER (UNII: OZ0 E5Y15PZ)

INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)

SHEA BUTTER (UNII: K49 155WL9 Y)

C13 -14 ISO PARAFFIN (UNII: E4F12ROE70 )

CANNABIS SATIVA SEED O IL (UNII: 6 9 VJ1LPN1S)

CARBO XYPO LYMETHYLENE (UNII: 0 A5MM30 7FC)

CENTELLA ASIATICA LEAF (UNII: 6 8 10 0 70 TYD)

CHO LESTERO L (UNII: 9 7C5T2UQ7J)

DIMETHICO NE (UNII: 9 2RU3N3Y1O)

DIMETHYL ISO SO RBIDE (UNII: SA6 A6 V432S)

GLYCYRRHIZINATE DIPO TASSIUM (UNII: CA2Y0 FE3FX)

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

EMU O IL (UNII: 3448 21WD6 1)

DIETHYLENE GLYCO L MO NO ETHYL ETHER (UNII: A1A1I8 X0 2B)

EUCALYPTUS O IL (UNII: 2R0 4ONI6 6 2)

GLYCERIN (UNII: PDC6 A3C0 OX)

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

SUNFLO WER O IL (UNII: 3W1JG79 5YI)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

LAURETH-7 (UNII: Z9 5S6 G8 20 1)

LAVENDER O IL (UNII: ZBP1YXW0 H8 )

TEA TREE O IL (UNII: VIF56 5UC2G)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PO LYSO RBATE 2 0 (UNII: 7T1F30 V5YH)

WATER (UNII: 0 59 QF0 KO0 R)

PYRIDO XINE HYDRO CHLO RIDE (UNII: 6 8 Y4CF58 BV)

SO DIUM BENZO ATE (UNII: OJ245FE5EU)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packaging# Item Code Package Description Marketing Start Date Marketing End Date1 NDC:6 3742-0 13-0 0 6 5 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 1/20 19

2 NDC:6 3742-0 13-0 1 10 1 g in 1 BOTTLE; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 1/20 19

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 part348 0 5/0 1/20 19

Labeler - Clinical Resolution Laboratory, Inc. (825047942)

Revised: 5/2019