83559-016

83559-016
SPL v1
SPL
SPL Set ID 49ad128a-0f4c-085a-e063-6294a90ac9bb
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (3 g) Capsaicin (0.083 g)
Inactive Ingredients
Edetate Disodium Ethylhexylglycerin Phenoxyethanol Povidone K90 Dihydroxyaluminum Aminoacetate Anhydrous Glycerin Sodium Polyacrylate (2500000 Mw) Water Carboxymethylcellulose Sodium, Unspecified Tartaric Acid Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-31

Description

Menthol 3% Capsaicin 0.083%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 3% Capsaicin 0.083%

Use

Temporarily relieves minor pain associated with:

arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

Stop Use

STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

• redness is present • skin irritation develops

Warnings

EXTERNAL USE ONLY

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and Children 12 years of age and older:

• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions

• Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: DO NOT use without consulting a doctor.

When Using

• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

Active Ingredient

Menthol 3%

Capsaicin 0.083%

Other Information

For fast relief of minor aches and pains due to:

• Arthritis

• Strains

• Bruises

• Sprains

EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.

FAST-ACTING PAIN RELIEF

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

Inactive Ingredients

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel

Keep Out of Reach of Children

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Structured Label Content

Use

Temporarily relieves minor pain associated with:

arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps

Purpose

Topical Analgesic

Stop Use

STOP USE and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days

• redness is present • skin irritation develops

Warnings

EXTERNAL USE ONLY

Ask Doctor

If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and Children 12 years of age and older:

• Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions

• Apply to affected area not more than 3 to 4 times daily

Children under 12 years of age: DO NOT use without consulting a doctor.

When Using

• USE ONLY AS DIRECTED • do not bandage tightly or use with a heating pad • avoid contact with eyes and mucous membranes • do not apply to wounds or damaged skin.

Active Ingredient

Menthol 3%

Capsaicin 0.083%

Other Information (Other information)

For fast relief of minor aches and pains due to:

• Arthritis

• Strains

• Bruises

• Sprains

EXTRA STRENGTH PAIN RELIEF HOT PATCH soothes and relieves pain associated with minor aches and pains. It is ideal for small areas such as arm, neck and leg.

FAST-ACTING PAIN RELIEF

Distributed by:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

Inactive Ingredients (Inactive ingredients)

Aluminum Glycinate, Edetate Disodium, Ethylhexylglycerin, Glycerin, Phenoxyethanol, Polyvinylpyrrolidone, Sodium Carboxy-methylcellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

KEEP OUT OF REACH OF CHILDREN.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)