Capsaicin Heat Patch

Capsaicin Heat Patch
SPL v7
SPL
SPL Set ID b3b40f77-3b0b-4111-968b-f3a87a5701fa
Route
TOPICAL
Published
Effective Date 2025-10-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-03-07 Until 2027-12-31

Description

Capsicum Extract Capsaicin 0.025%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Extract Capsaicin 0.025%

Uses

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

• Simple Backache  • Arthritis  • Strains  • Bruises  • Sprains

Section 42229-5

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

Section 50565-1

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

Packaging

Warnings:

EXTERNAL USE ONLY

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 this product

• 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

STOP USE and ask a doctor if

• 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

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

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

Children under 12 years of age: Consult a doctor.

Drug Facts

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Other Information

• Avoid storing product in direct sunlight

• Protect product from excessive moisture

Inactive Ingredients

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


Structured Label Content

Uses

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

• Simple Backache  • Arthritis  • Strains  • Bruises  • Sprains

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Topical Analgesic

Packaging

Warnings: (WARNINGS:)

EXTERNAL USE ONLY

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 this product

• 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

STOP USE and ask a doctor if

• 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

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

Directions (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

Children under 12 years of age: Consult a doctor.

Drug Facts

Active Ingredient

Capsicum Extract Capsaicin 0.025%

Other Information

• Avoid storing product in direct sunlight

• Protect product from excessive moisture

Inactive Ingredients

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


Advanced Ingredient Data


Raw Label Data

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