MENTHOLATUM SPORTS PAIN RELIEF COLD- menthol gel
The Mentholatum Company

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredients

Menthol 2%

Purpose

Menthol - Topical analgesic

Uses

temporarily relieves minor aches and pains of muscles and joints due to

•: simple backache
•: strains
•: sprains
•: bruises

Warnings

For external use only

When using this product

•: use only as directed
•: do not bandage tightly
•: do not get into eyes or on mucous membranes
•: do not apply to wounds or damaged skin
•: do not use with a heating pad or apply external heat
•: do not use in combination with other external analgesic products

Stop use and ask a doctor if

•: condition worsens
•: excessive irritation, burning or discomfort of the skin develops
•: symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

•: adults and children 12 years and over: apply a small amount to affected area not more than 3 to 4 times daily
•: children under 12 years: ask a doctor

Inactive ingredients

blue 1, carbomer, isopropyl alcohol, methylparaben, propylparaben, purified water, trolamine

Questions?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Package/Label Principal Display Panel

Mentholatum Sports Pain Relief Gel - Cold

MENTHOLATUM SPORTS PAIN RELIEF COLD
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10742-8147
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10742-8147-1	255 g in 1 JAR; Type 0: Not a Combination Product	06/15/2013	07/01/2016

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part348	06/15/2013	07/01/2016

Labeler - The Mentholatum Company (002105757)

Revised: 11/2016

Document Id: dd7bc8f2-f847-4f65-9d38-95ac570b4f0b

Set id: e1d40780-4873-4e5b-a82b-a014a86c70a9

Version: 2

Effective Time: 20161104

The Mentholatum Company