COOL HEAT- menthol and methyl salicylate cream

Cool Heat by

Drug Labeling and Warnings

Cool Heat by is a Otc medication manufactured, distributed, or labeled by Dolgencorp Inc, Anicare Pharmaceuticals Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Menthol                 10%

Methyl salicylate    30%

PURPOSE

Purpose

Topical analgesic

INDICATIONS & USAGE

Uses

temporarily relieves minor pain associated with:

• arthritis
• simple backache
• muscle strains
• sprains
• bruises
• cramps

WARNINGS

Warnings

For external use only

Allergy alert: If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

When using this product

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

When using this product

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

If pregnant or breast-feeding, ask a health care professional before use.

Keep out of reach of children.

If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Adults and Children over 12 years:

• apply generously to affected area
• massage into painful area until thoroughly absorbed into skin
• repeat as necessary, but not more than 4 times daily

Children 12 years or younger: ask a doctor

INACTIVE INGREDIENT

Inactive ingredients

carbomer, cetyl esters, emulsifying wax, oleth-3 phosphate, stearic acid, triethanolamine, water.

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL
EXTRA STRENGTH
COOL HEAT PAIN RELIEVING CREAM
NET WT 1.25 OZ (35 g)

INGREDIENTS AND APPEARANCE

COOL HEAT 
menthol and methyl salicylate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-405
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	10 g  in 100 g
METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	METHYL SALICYLATE	30 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
CETYL ESTERS WAX (UNII: D072FFP9GU)
OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-405-35	35 g in 1 TUBE; Type 0: Not a Combination Product	06/29/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/29/2016

Labeler - Dolgencorp Inc (068331990)

Registrant - Anicare Pharmaceuticals Pvt. Ltd (916837425)

Establishment
Name	Address	ID/FEI	Business Operations
Anicare Pharmaceuticals Pvt. Ltd		916837425	manufacture(55910-405)