EXTRA STRENGTH COLD AND HOT MENTHOL PATCH- menthol patch 
Rite Aid Corporation

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 Strength Cold & Hot Menthol Patch

Active Ingredients

Menthol 5% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Analgesic

Uses

Temporarily relieves minor pain.

Warnings

For external use only.

When using this product

■ use only as directed

■ rear cases of serious burns have been reported with products of this type

■ Don't bandage tightly or use with a heating pad

■ Avoid contact with the 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 consult 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.

Keep out of reach of children and pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Dosage and Administration

Directions Adults and children 12 years of age and over :

■ Carefully remove backing from patch

■ Apply sticky side of patch to affected area.

■ Wear 1 patch up to 8 hours. Repeat as necessary, but no more than 3 times daily..

■ Discard patch after single use.

■Reseal pouch after opening.

■Children under 12 years of age: consult a physician.

Other Safety Information

Store at room temperature, not to exceed 86F (30C)

Inactive Ingredients

Carboxymethylcellulose Sodium, Dihydroxyaluminum Aminoacetate, Glycerin, iodopropynyl butylcarbamate, Kaolin, mineral oil, petrolatum, Phenoxyethanol, polyacrylic acid, Polysorbate 80, Povidone, Propylene Glycol, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water, 3-(2-ethylhexyloxy)propane-1,2-diol

Uses

Temporarily relieves minor pain.

Extra Strength Cold & Hot Menthol Patch

label

EXTRA STRENGTH COLD AND HOT MENTHOL PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-6513
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A) MENTHOL, UNSPECIFIED FORM5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
PETROLATUM (UNII: 4T6H12BN9U)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
MINERAL OIL (UNII: T5L8T28FGP)  
Product Characteristics
Color    Score    
ShapeRECTANGLESize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-6513-15 in 1 CARTON03/01/2021
11 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/01/2021
Labeler - Rite Aid Corporation (014578892)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech529128763manufacture(11822-6513)

Revised: 1/2023
Document Id: f20494e3-24a0-ad8b-e053-2995a90a153d
Set id: bd46ac50-aaf8-b4e8-e053-2995a90aea61
Version: 3
Effective Time: 20230111
 
Rite Aid Corporation