LIGHTNING PAIN RELIEF- menthol cream

Lightning Pain Relief by

Drug Labeling and Warnings

Lightning Pain Relief by is a Otc medication manufactured, distributed, or labeled by Clinical Resolution Laboratory, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 if

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

When using this product

• avoid contact with the eyes or mucous membranes 
• do not use with other ointments, creams, sprays or liniments
• do not apply to irritated skin or if excessive irritation develops
• do not apply to wounds or damaged skin 
• do not use with heating pad or device 
• do not bandage

Stop use and ask a doctor if

Condition worsens, or if symptoms persist more than 7 days, or clear up and reoccur.

Keep out of reach of children

if swallowed, call your Poison Control Center at 1 (800) 222-1222.

Directions

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

Other Information

• store 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), SD Alcohol 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)

INGREDIENTS AND APPEARANCE

LIGHTNING PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63742-013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
INDIAN FRANKINCENSE (UNII: 4PW41QCO2M)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
CANNABIS SATIVA SEED OIL (UNII: 69VJ1LPN1S)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CENTELLA ASIATICA LEAF (UNII: 6810070TYD)
CHOLESTEROL (UNII: 97C5T2UQ7J)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
EMU OIL (UNII: 344821WD61)
DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)
EUCALYPTUS OIL (UNII: 2R04ONI662)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
LAURETH-7 (UNII: Z95S6G8201)
LAVENDER OIL (UNII: ZBP1YXW0H8)
TEA TREE OIL (UNII: VIF565UC2G)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
WATER (UNII: 059QF0KO0R)
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV)
SODIUM BENZOATE (UNII: OJ245FE5EU)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63742-013-00	65 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019
2	NDC: 63742-013-01	101 g in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2019

Labeler - Clinical Resolution Laboratory, Inc. (825047942)