THERACARE 5% MENTHOL PAIN RELIEF PATCH- menthol patch

Theracare 5% Menthol Pain Relief Patch by

Drug Labeling and Warnings

Theracare 5% Menthol Pain Relief Patch by is a Otc medication manufactured, distributed, or labeled by Veridian Healthcare, Unexo Life Sciences Private Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

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

PURPOSE

Topical Analgesic

INDICATIONS & USAGE

Temporarily relieves minor pain associated with: ■ arthritis ■ simple backache ■ bursitis ■ tendonitis ■ muscle strains ■ muscle sprains ■ bruises ■ 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 of skin injury, such as 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, not to exceed 86ºF (30ºC)

INACTIVE INGREDIENT

Inactive ingredients

alcohol, carboxymethylcellulose sodium, dihydroxyaluminum aminoacetate, edetate disodium, glycerin, kaolin, methacrylic ac d and ethyl acrylate copolymer, methylparaben, polysorbate 80, polyvinyl alcohol, povidone, propylparaben, sodium polyacrylate, sorb tan monooleate, sorb tol, tartaric acid, titanium dioxide, water

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

THERACARE 5% MENTHOL PAIN RELIEF PATCH 
menthol patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71101-053
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)
ALCOHOL (UNII: 3K9958V90M)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
METHACRYLIC ACID AND ETHYL ACRYLATE COPOLYMER (UNII: NX76LV5T8J)
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)
METHYLPARABEN (UNII: A2I8C7HI9T)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
KAOLIN (UNII: 24H4NWX5CO)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
TARTARIC ACID (UNII: W4888I119H)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71101-053-05	5 in 1 BOX	08/01/2024
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	08/01/2024

Labeler - Veridian Healthcare (830437997)

Establishment
Name	Address	ID/FEI	Business Operations
Unexo Life Sciences Private Ltd.		872260479	manufacture(71101-053)