Cooln Heat Muscle Rub Well At Walgreens: Package Insert and Label Information

COOLN HEAT MUSCLE RUB WELL AT WALGREENS- menthol gel
Walgreens

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.

Active ingredient Purpose

Menthol 2.5% Topical Analgesic

Uses

temporarily reliefs minor pain associated with • arthritis • simple backache •strains • bruises

Warnings For 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

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Menthol (MENTHOL) Menthol 2.5 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
Alcohol
Allantoin
ALOE VERA LEAF
DMDM Hydantoin
Glycerin
Methylparaben
Phenoxyethanol
Propylparaben
Steareth-2
Steareth-21
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-7002-03 1 TUBE in 1 CARTON contains a TUBE
1 89 mL in 1 TUBE This package is contained within the CARTON (0363-7002-03)
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 Operations
Product Quest Mfg. 927768135 manufacture (0363-7002), label (0363-7002)

Revised: 02/2018 Walgreens

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