83559-013

83559-013
SPL v1
SPL
SPL Set ID 49ac2045-2c07-af9a-e063-6294a90a052a
Route
TOPICAL
Published
Effective Date 2026-01-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Capsaicin (0.025 g)
Inactive Ingredients
Camphor (synthetic) Lanolin Styrene/isoprene Copolymer (28:72; 210000 Mw) Menthol, Unspecified Form Eucalyptus Oil Peppermint Oil Zinc Oxide Methyl Salicylate

Identifiers & Packaging

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

Description

Capsicum Extract Capsaicin 0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Extract Capsaicin 0.025%

Use

For temporary relief of minor aches and pains of muscles & joints associated with:

• Simple Backache • Arthritis • Strains • Bruises • Sprains

Section 51945-4

Stop Use

• rash, itching or excessive skin irritation develops

• conditions worsen

• symptoms persist for more than 7 days

• symptoms clear up and occur again within few days

Warnings

EXTERNAL USE ONLY

Questions

www.universaldc.com

Ask Doctor

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

Children under 12 years of age: Consult a doctor.

Directions

Adults and Children 12 years of age and over:

Clean and dry affected area

Remove patch from film

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

Remove patch from skin after at most 8 hours of application

Do Not Use

• on wounds or damaged skin

• with a heating pad

• with or at the same times as other external analgesic

• if you are allergic to any ingredients of this product

When Using

• do not use otherwise than as directed

• avoid contact with the eyes, mucous membranes or rashes

• do not bandage tightly

• discontinue use at least 1 hour before a bath or shower

• do not use immediately after a bath or shower

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Other Information

• Avoid storing product in direct sunlight

• Protect product from excessive moisture

Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®

*This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.

Distributed By:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive Ingredients

camphor, eucalyptus oil, lanolin, peppermint oil, menthol, methyl salicylate, styrene/isoprene copolymer, zinc oxide

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

For temporary relief of minor aches and pains of muscles & joints associated with:

• Simple Backache • Arthritis • Strains • Bruises • Sprains

Section 51945-4 (51945-4)

Purpose

Topical Analgesic

Stop Use

• rash, itching or excessive skin irritation develops

• conditions worsen

• symptoms persist for more than 7 days

• symptoms clear up and occur again within few days

Warnings

EXTERNAL USE ONLY

Questions

www.universaldc.com

Ask Doctor

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

Children under 12 years of age: Consult a doctor.

Directions

Adults and Children 12 years of age and over:

Clean and dry affected area

Remove patch from film

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

Remove patch from skin after at most 8 hours of application

Do Not Use (Do not use)

• on wounds or damaged skin

• with a heating pad

• with or at the same times as other external analgesic

• if you are allergic to any ingredients of this product

When Using

• do not use otherwise than as directed

• avoid contact with the eyes, mucous membranes or rashes

• do not bandage tightly

• discontinue use at least 1 hour before a bath or shower

• do not use immediately after a bath or shower

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Other Information (Other information)

• Avoid storing product in direct sunlight

• Protect product from excessive moisture

Compare to the active ingredient in Salonpas® - Hot Capsicum Patch®

*This product is NOT manufactured or distributed by Hisamitsu®, owner of Salonpas® Hot Capsicum Patch.

Distributed By:

Universal Distribution Center

96 Distribution Boulevard • Edison, NJ 08817

MADE IN CHINA

www.universaldc.com

Inactive Ingredients (Inactive ingredients)

camphor, eucalyptus oil, lanolin, peppermint oil, menthol, methyl salicylate, styrene/isoprene copolymer, zinc oxide

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

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