COOLN HEAT MUSCLE RUB WELL AT WALGREENS- menthol gel

Cooln Heat Muscle Rub by

Drug Labeling and Warnings

Cooln Heat Muscle Rub by is a Otc medication manufactured, distributed, or labeled by Walgreens, Product Quest Mfg.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                    Purpose

Menthol  2.5%                         Topical Analgesic

Uses

temporarily reliefs minor pain associated with arthritis simple backache strains bruises

PURPOSE

WarningsFor external use only

​When using this product​

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

KEEP OUT OF REACH OF CHILDREN

Directions

​Adults and childern over 12 years:

• squeeze desired amount of pain relieving gel into painful area until throughly absorbed
• repeat as necessary, but not more than 4 times daily

​Children 12 years or younger:​ ask a doctor

Inaction ingredients

Alcohol Denat.
Allantoin
Aloe Barbadensis Leaf Extract
Carbomer
DMDM Hydantoin
Glycerin
Methylparaben
Phenoxyethanol
Propylparaben
Steareth-2
Steareth-21
Triethanolamine
Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLN HEAT MUSCLE RUB  WELL AT WALGREENS
menthol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0363-7002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Menthol (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	Menthol	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
Alcohol (UNII: 3K9958V90M)
Allantoin (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
DMDM Hydantoin (UNII: BYR0546TOW)
Glycerin (UNII: PDC6A3C0OX)
Methylparaben (UNII: A2I8C7HI9T)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylparaben (UNII: Z8IX2SC1OH)
Steareth-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0363-7002-03	1 in 1 CARTON	07/11/2016
1		89 mL in 1 TUBE; 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	07/11/2016

Labeler - Walgreens (008965063)

Registrant - Product Quest Mfg. (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg.		927768135	manufacture(0363-7002) , label(0363-7002)