HEALTHWISE COLD THERAPY PAIN RELIEF PATCH- menthol patch

HealthWise Cold Therapy Pain Relief Patch by

Drug Labeling and Warnings

HealthWise Cold Therapy Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Foshan Aqua Gel Biotech Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Menthol 5%

Purpose

Topical analgesic

Use

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

■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 consult a doctor if

o condition worsens

o redness is present

o irritation develops

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

o you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding

ask a health professional before use.

Keep out of reach of children and pets

Directions

Directions
■ Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove back ng starting at a corner. 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, not to exceed 86'F (30'C).

Inactive Ingredient

aloe vera extract, arnica montana extract, boswellia carterii resin extract, carboxymethylcellulose sodium, ethylhexylglycerin, dihydroxyaluminum aminoacetate, glycerin, green tea extract, iodopropynyl butylcarbamate, kaolin, mineral oil, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

HealthWise Cold Therapy Pain Relief Patch

INGREDIENTS AND APPEARANCE

HEALTHWISE COLD THERAPY PAIN RELIEF PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-950
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE (UNII: FZ989GH94E)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)
MINERAL OIL (UNII: T5L8T28FGP)
WATER (UNII: 059QF0KO0R)
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
FRANKINCENSE (UNII: R9XLF1R1WM)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-950-15	15 in 1 CARTON	12/01/2023
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 Drug	M017	12/01/2023

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Foshan Aqua Gel Biotech Co., Ltd.		529128763	manufacture(71101-950)