Pain Relief Hot Patch

Pain Relief Hot Patch
SPL v7
SPL
SPL Set ID 110bcb16-ef0b-4bc8-8877-173a0494e1ad
Route
TOPICAL
Published
Effective Date 2026-01-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (30 mg) Capsaicin (0.83 mg)
Inactive Ingredients
Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Ethylhexylglycerin Glycerin Phenoxyethanol Povidone K90 Carboxymethylcellulose Sodium, Unspecified Sodium Polyacrylate (2500000 Mw) Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-03-23

Description

Menthol 3% Capsaicin 0.083%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Menthol 3% Capsaicin 0.083%

Uses

Temporarily relieves minor pain associated with:

  • arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps
Section 42229-5

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

Packaging

Warnings:

EXTERNAL USE ONLY

When using this product 

• 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.

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

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.

Drug Facts

Active Ingredients

Menthol 3%

Capsaicin 0.083%

Inactive Ingredients

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

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

Uses

Temporarily relieves minor pain associated with:

  • arthritis • simple backache • bursitis • tendonitis • muscle strains • bruises • cramps
Section 42229-5 (42229-5)

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

Purpose

Topical Analgesic

Packaging

Warnings: (WARNINGS:)

EXTERNAL USE ONLY

When using this product 

• 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.

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

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

Directions (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.

Drug Facts

Active Ingredients

Menthol 3%

Capsaicin 0.083%

Inactive Ingredients

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

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

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