HEALTHWISE MEDICATED COLD HOT 5%- menthol patch

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Topical Analgesic

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.

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.

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

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.

Other information

Store at room temperature. Avoid direct sunlight. Protect from excessive moisture

INACTIVE INGREDIENT

Alcohol, Aluminum Glycinate, Benzyl alcohol, Carboxymethylcellulose sodium, Edetate disodium, Ethylhexylglycerin, Glycerin, Isopropyl Myristate,Kaolin, Methacrylate copolymer, Phenoxyethanol, Polysorbate 80, Povidone, Sodium polyacrylate,Sorbitan Monooleate, Sorbitol, Tartaric acid, Titanium dioxide, Water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HEALTHWISE MEDICATED COLD HOT 5% 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-084
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
SORBITOL (UNII: 506T60A25R)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
ALCOHOL (UNII: 3K9958V90M)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-084-15	15 in 1 BOX	04/01/2026
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/01/2026

Labeler - Veridian Healthcare (830437997)