DRUG FACTS

Active Ingredient

Menthol (5%)

Purpose

Topical Analgesic

Uses

Provides penetrating temporary relief for minor pain in muscles and joints associated with:

Backache
Arthritis
Bruises
Sprains

Warnings

For external use only.

Do not use

with a heating pad. Do not apply to wounds or damaged skin. Do not bandage tightly after use.
Avoid contact with eyes.
Discontinue use and consult a physician if condition worsens, or if symptoms persist more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help or contact a poison control center right away.

Directions

Apply generously to affected area. Massage well into painful area. Repeat as necessary, but not more than 3 to 4 times daily. Adults and children over the age of 2:

Do not use; consult a physician. Children under the age of 2:

Inactive Ingredients

Water, Propanediol, Isononyl Isononanoate, Cetearyl Alcohol, Ethylhexyl Palmitate, Prunus Amygdalus Dulcis (Sweet Almond) Oil 1%, Phenoxyethanol, Stearic Acid, Arginine, Cetearyl Glucoside, Carbomer, Polysorbate 60, Caprylyl Glycol, Xanthan Gum, Tocopherol, Ethylhexylglycerin, Aloe Barbadensis Leaf Juice, Glycerin, Zingiber Officinale (Ginger) Root Extract.

Package Labeling:

JOINT AND MUSCLE PAIN
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:59899-022
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	50 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
PROPANEDIOL (UNII: 5965N8W85T)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ALMOND OIL (UNII: 66YXD4DKO9)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
STEARIC ACID (UNII: 4ELV7Z65AP)
ARGININE (UNII: 94ZLA3W45F)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
POLYSORBATE 60 (UNII: CAL22UVI4M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
XANTHAN GUM (UNII: TTV12P4NEE)
TOCOPHEROL (UNII: R0ZB2556P8)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
GINGER (UNII: C5529G5JPQ)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:59899-022-00	85 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	01/01/2020

Labeler - Shaklee Corporation (129469263)

Joint & Muscle Pain Cream