MENTHOGEL PAIN RELIEF- menthol cream

MENTHOGEL Pain Relief by

Drug Labeling and Warnings

MENTHOGEL Pain Relief by is a Otc medication manufactured, distributed, or labeled by Care Code, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts:

Active ingredient

Menthol 2.60%

Topical Analgesic

Indications:

For the temporary relief of minor aches and pains of the muscles and joints associated with arthritis, simple backache, sprains, bruises and strains

Warnings:

• For external use only.
• Avoid contact with eyes.
• If symptoms persist for more than seven days, discontinue use and consult physician.

Keep out of reach of children.

• If swallowed, consult physician.
• Do not apply to wounds or damaged skin.
• Do not bandage tightly.

If pregnant or breast-feeding,

contact physician prior to use.

Directions:

• Adults and children two-years of age or older: Apply to affected area not more than three to four times daily. 
• Children under two-years of age: Consult a physician..

Additional Information:

• Store at room temperature.

Other Ingredients

Acrylates Copolymer, Aqua (Deionized Water), Caprylyl Glycol, Chamomilla Recutita (Chamomile) Extract, Isopropyl Myristate, Melaleuca Alternifolia (Tea Tree) Oil, Olea Europaea (Olive) Oil, Phenoxyethanol, Polysorbate-20, Propylene Glycol, Prunus Amygdalus Dulcis (Almond) Oil, Triethanolamine, FD&C Yellow #5.

Package Labeling:

INGREDIENTS AND APPEARANCE

MENTHOGEL PAIN RELIEF 
menthol cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72613-275
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	26 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
WATER (UNII: 059QF0KO0R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CHAMOMILE (UNII: FGL3685T2X)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
TEA TREE OIL (UNII: VIF565UC2G)
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
ALMOND (UNII: 3Z252A2K9G)
TROLAMINE (UNII: 9O3K93S3TK)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72613-275-04	118 mL in 1 JAR; Type 0: Not a Combination Product	09/14/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/14/2018

Labeler - Care Code, Inc (115615985)