EXTRA STRENGTH COLD AND HOT MENTHOL PATCH- menthol patch

Extra Strength Cold and Hot Menthol Patch by

Drug Labeling and Warnings

Extra Strength Cold and Hot Menthol Patch by is a Otc medication manufactured, distributed, or labeled by Rite Aid Corporation, Foshan Aqua Gel Biotech. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PREGNANCY OR BREAST FEEDING

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

INGREDIENTS AND APPEARANCE

EXTRA STRENGTH COLD AND HOT MENTHOL PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-6513
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) (MENTHOL, UNSPECIFIED FORM - UNII:L7T10EIP3A)	MENTHOL, UNSPECIFIED FORM	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape	RECTANGLE	Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-6513-1	5 in 1 CARTON	03/01/2021
1		1 g in 1 PATCH; 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	03/01/2021

Labeler - Rite Aid Corporation (014578892)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech		529128763	manufacture(11822-6513)