EQUATE COOL AND HEAT EXTRA STRENGTH- menthol patch

Equate Cool and Heat by

Drug Labeling and Warnings

Equate Cool and Heat by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Menthol 5%

Purpose

Menthol - Topical analgesic

Uses

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

• arthritis
• simple backache
• strains
• sprains
• bursitis
• tendonitis
• bruises
• cramps

Warnings

For external use only

When using this product

• use only as directed
• avoid contact with eyes or on mucous membranes
• do not apply to wounds or to damaged or very sensitive skin
• do not bandage tightly or use a heating pad

Stop use and ask a doctor if

• excessive redness or irritation is present
• condition worsens
• pain persists for more than 7 days
• symptoms 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 patch to affected area as needed but no more than 4 times daily
• children under 12 years: ask a doctor
• for easy application: grasp both ends of pad firmly, pull at both ends. Stretch pad until the backing separates. Remove protective film while applying pad directly to site of pain.

Inactive ingredients

carbomer homopolymer, carboxymethylcellulose sodium, castor oil, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxypropyl cellulose, kaolin, partially neutralized polycrylate, polyvinyl alcohol, purified water, sorbitol solution, tartaric acid

Questions?

Call: 1-888-287-1915

Package/Label Principal Display Panel

Package/Label Principal Display Panel

INGREDIENTS AND APPEARANCE

EQUATE COOL AND HEAT  EXTRA STRENGTH
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-888
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	50 mg

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
CASTOR OIL (UNII: D5340Y2I9G)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)
WATER (UNII: 059QF0KO0R)
SORBITOL (UNII: 506T60A25R)
TARTARIC ACID (UNII: W4888I119H)
HYDROXYPROPYL CELLULOSE (70000 WAMW) (UNII: 66O7AQV0RT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-888-30	1 in 1 CARTON	07/01/2014
1		5 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/01/2014

Labeler - Wal-Mart Stores Inc (051957769)