SPL v1
SPL
SPL Set ID 3b5fd718-3f86-f7a7-e063-6294a90a8c52
Route
TOPICAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.25 g) Menthol (5 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Polyvinyl Alcohol Tartaric Acid Glycerin Water Glucosamine Edetate Disodium Dihydroxyaluminum Aminoacetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Menthol 5% Capsaicin 0.25%.


Medication Information

Warnings and Precautions

WarningsFor externaluse only.

Indications and Usage

i adults and children 12 years of age and older: Clean and dry affected area, pop apartand partiallypeel back protective film and apply exposed patch to site of pain. Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily.children under 12 years of age: consult a physicianwash hands after use with cool water

Dosage and Administration

Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily

Description

Menthol 5% Capsaicin 0.25%.

Section 50565-1

Keep out of reach of children. lfswallowed, get medical help or contact a Poison ControlCenter right away.

Section 50566-9

you experience pain, swelling or blistering of the skinicondition worsens, or if symptoms persist for more than 7 days or clear up and occuragain within afew daysarthritic pain persists for more than 10 days, or redness is present

Section 50567-7

use only as directed avoid contact with the eyes or on mucous membranes

do not apply to wounds or damaged skin

do not apply to irritated skin or if excessive irritation

do not bandage tightly or use with heating pad or device

Section 51727-6

Inactive ingredients

Sodium polyacrylate,Aluminium glycinat,Disodium edetate dihydrate,Purified water,Tartaric acid ,polyving alcohol,Glucosamine,gl ycerol.

Section 51945-4

Section 55105-1

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:simple backache, arthritis

,strains,bruises,sprains

Section 55106-9

Menthol 5%

Capsaicin 0.25%.


Structured Label Content

Indications and Usage (34067-9)

i adults and children 12 years of age and older: Clean and dry affected area, pop apartand partiallypeel back protective film and apply exposed patch to site of pain. Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily.children under 12 years of age: consult a physicianwash hands after use with cool water

Dosage and Administration (34068-7)

Carefullyremove remaining filmwhile pressing the patch to skin and leave in place for up to 8hours. Use on affected area not morethan 3 to 4 times daily

Warnings and Precautions (34071-1)

WarningsFor externaluse only.

Section 50565-1 (50565-1)

Keep out of reach of children. lfswallowed, get medical help or contact a Poison ControlCenter right away.

Section 50566-9 (50566-9)

you experience pain, swelling or blistering of the skinicondition worsens, or if symptoms persist for more than 7 days or clear up and occuragain within afew daysarthritic pain persists for more than 10 days, or redness is present

Section 50567-7 (50567-7)

use only as directed avoid contact with the eyes or on mucous membranes

do not apply to wounds or damaged skin

do not apply to irritated skin or if excessive irritation

do not bandage tightly or use with heating pad or device

Section 51727-6 (51727-6)

Inactive ingredients

Sodium polyacrylate,Aluminium glycinat,Disodium edetate dihydrate,Purified water,Tartaric acid ,polyving alcohol,Glucosamine,gl ycerol.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with:simple backache, arthritis

,strains,bruises,sprains

Section 55106-9 (55106-9)

Menthol 5%

Capsaicin 0.25%.


Advanced Ingredient Data


Raw Label Data

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