EXTRA LARGE COOL AND HEAT PATCH- menthol patch 
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.

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Extra Large Cool and Heat Patch

ACTIVE INGREDIENT

Active Ingredient ...............................................................................................Purpose
Menthol 5%...............................................................................................Topical Analgesic

INACTIVE INGREDIENT

CMC, Dihydroxy aluminum Aminoacetate, Glycerin, Kaolin, Mineral Oil, Methylparaben, Petrolatum, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

KEEP OUT OF REACH OF CHILDREN

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (800-222-1222) right away.

INDICATIONS & USAGE

For temporary relief of minor aches and pains of muscles and joints: arthritis, simple backache, bursitis, tendonitis, muscle strains, muscle sprains, bruises and cramps.

WARNINGS

For External Use Only.

DOSAGE & ADMINISTRATION

Adults and children over 12 years: Carefully remove backing from patch. Apply sticky side of patch to affected area.

Wear one patch up to 8 hours. Repeat as necessary, but no more than 3 times daily. Reseal pouch after opening.

Children 12 years or younger: Consult a physician.

PURPOSE

Topical Analgesic

When using this product

When using this product ■ Use only as directed ■ Rare cases of serious burns have been reported with products of this type ■ Don’t bandage tightly or use with heating pad ■ Avoid contact with eyes and mucous membranes ■ Don’t apply to wounds or damaged skin ■ Do not use at the same time as other topical analgesics.

Stop use and ask a doctor

■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

If pregnant or breastfeeding

ask a health professional before use.

label

EXTRA LARGE COOL AND HEAT PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-9905
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
MINERAL OIL (UNII: T5L8T28FGP)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0363-9905-033 in 1 BOX01/01/2020
19 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/2020
Labeler - Walgreen Company (008965063)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co.,Ltd.529128763manufacture(0363-9905)

Revised: 1/2023
Document Id: f2033ba9-1bd5-a446-e053-2995a90a0762
Set id: 9fd83f89-0dd0-4f22-9c8e-a353864ea43b
Version: 3
Effective Time: 20230111
 
Walgreen Company