HEALTHWISE MEDICATED COLD HOT 5% PATCH- menthol patch 
Veridian Healthcare

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HealthWise Medicated Cold Hot 5% Menthol Patch

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.

Packlabel

HEALTHWISE MEDICATED COLD HOT 5% PATCH 
menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71101-031
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71101-031-066 in 1 BOX04/01/2024
11 in 1 POUCH; Type 0: Not a Combination Product
2NDC:71101-031-2525 in 1 BOX04/01/2024
21 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01704/01/2024
Labeler - Veridian Healthcare (830437997)
Establishment
NameAddressID/FEIBusiness Operations
Foshan Aqua Gel Biotech Co., Ltd.,529128763manufacture(71101-031)

Revised: 4/2024
Document Id: 165020f4-d79e-a602-e063-6294a90a269b
Set id: 15aef56f-cd25-05ac-e063-6394a90a07bb
Version: 2
Effective Time: 20240417
 
Veridian Healthcare