Active ingredient

Menthol 10%

Purpose

Topical Analgesic

Uses:

Temporary relief from minor aches and pains of sore muscles and joints associated with:

arthritis
backache
strains
sprains

Warnings:

For external use only

Ask a doctor before use if you have: Sensitive skin

Flammable:Keep away from excessive heat or open flame.

When using this product:

Avoid contact with the eyes or mucous membranes
Do not apply to wounds or damaged skin
Do not use with other ointments, creams, sprays or liniments
Do not apply to irritated skin or if excessive irritation develops
Do not bandage
Wash hands after use with cool water
Do not use with heating pad or device
Store in a cool dry place, away from sunlight

Stop use and ask a doctor if:

Condition worsens, or if symptoms persist for more than 7 days, or clear up and recur

If pregnant or breastfeeding:

Ask a health professional before use.

Keep out of reach of children and pets:If accidentally ingested, get medical help or contact a Poison Control Center immediately

Directions:

Adults and Children 12 years of age and older:

Rub a thin film over affected areas not more than 4 times daily; massage not necessary
Children under 12 years of age: Consult physician

Inactive Ingredients:

Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Gluconolactone, Glycerin, Glyceryl Stearate, Ilex Paraguarensis Leaf Extract, Phenoxyethanol, Polysorbate 60, Sodium Hydroxide, Tocopheryl Acetate (Vitamin E), Vitis Vinifera (Grape) Seed Oil, Water.

Principal Display Panel – 113.3 g Tube Label

cvs
Health ®

Compare to the active ingredient in Biofreeze ®Pain Relieving Foot Cream*

Pain Relieving Foot Cream

MENTHOL 10%

Temporarily relieves painful, achy feet
Soothes aggravated nerves

NET WT 4 OZ (113.3 g)

Principal Display Panel – 113.3 g Tube Label

CVS HEALTH PAIN RELIEF FOOT
menthol, unspecified form cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66902-292
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	100 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 60 (UNII: CAL22UVI4M)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GRAPE SEED OIL (UNII: 930MLC8XGG)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66902-292-04	113 g in 1 TUBE; Type 0: Not a Combination Product	10/22/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	10/22/2021

Labeler - NATURAL ESSENTIALS, INC. (947484713)

Name	Address	ID/FEI	Business Operations
Establishment
NATURAL ESSENTIALS, INC.		947484713	manufacture(66902-292)

Drug Facts