HEALTHWISE MEDICATED COLD HOT 5% PATCH- menthol patch

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient ...............................................................................................Purpose

Menthol 5%...............................................................................................Topical Analgesic
INACTIVE INGREDIENT

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
KEEP OUT OF REACH OF CHILDREN

Do not use on infants. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
INDICATIONS & USAGE

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis

■ muscle strains ■ muscle sprains ■ bruises ■ cramps
WARNINGS

For External Use Only.
DOSAGE & ADMINISTRATION

Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch. Apply sticky side of patch to affected area. Do not use more than one patch in an 8 hour period. Repeat as necessary. Maximum 3 patches per day. Discard patch after single use. Reseal pouch after opening.

Children under 12 years of age: 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

If condition worsens ■ If redness is present ■ If irritation develops

■ If symptoms persist for more than 7 days or clear up and occur again within a few days.

■ You experience signs injury, such a s pain, swelling, or blistering where the product was applied.
If pregnant or breastfeeding

ask a health professional before use.
PRINCIPAL DISPLAY PANEL

HEALTHWISE MEDICATED COLD HOT 5% PATCH
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-031
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	5 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC: 71101-031-06	6 in 1 BOX	04/01/2024
1		1 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 71101-031-25	25 in 1 BOX	04/01/2024
2		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M017	04/01/2024

Labeler - Veridian Healthcare (830437997)

Name	Address	ID/FEI	Business Operations
Establishment
Foshan Aqua Gel Biotech Co., Ltd.,		529128763	manufacture(71101-031)

HEALTHWISE MEDICATED COLD HOT 5% PATCH- menthol patch

HealthWise Medicated Cold Hot 5% Patch by

Drug Labeling and Warnings

Drug Details [pdf]