WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF: Package Insert and Label Information

WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF — menthol and methyl salicylate cream
WALGREEN 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.

Active ingredients Purpose

Menthol 10%……………………………………………………Topical Analgesic

Methyl Salicylate 30%………………………………………..Topical Analgesic

Uses temporarily relieves minor pain associated with:

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

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, damaged, broken or irritated skin

Stop use and ask a doctor if

  • Condition worsens
  • Symptoms persist for more than 7 days or clear up and occur again within a few days
  • Redness is present
  • Irritation develops

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

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away

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 no more than 4 times daily
  • Close cap tightly after use
  • Keep carton as it contains important information
  • Children 12 years or younger: Ask a doctor

Inactive ingredients DEA-cetyl phosphate, isopropyl myristate, methylparaben, polysorbate 60, propylparaben, purified lanolin, purified water, stearic acid, stearyl alcohol, trolamine

DISTRIBUTED BY: WALGREEN CO.

200 WILMOT RD., DEERFIELD, IL 60015

MADE IN KOREA

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WALGREENS COOL AND HEAT MUSCLE AND JOINT RELIEF
menthol, methyl salicylate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-0147
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
MENTHOL (MENTHOL) MENTHOL 10 g in 100 g
METHYL SALICYLATE (SALICYLIC ACID) METHYL SALICYLATE 30 g in 100 g
Inactive Ingredients
Ingredient Name Strength
CETYL ESTERS WAX
OLETH-3 PHOSPHATE
STEARIC ACID
TROLAMINE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0363-0147-30 1 TUBE (TUBE) in 1 CARTON contains a TUBE
1 85 g in 1 TUBE This package is contained within the CARTON (0363-0147-30)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/31/2013
Labeler — WALGREEN COMPANY (008965063)

Revised: 03/2013 WALGREEN COMPANY

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