Capsaicin by PHARMACURE LLC CAPSAICIN patch

Capsaicin by

Drug Labeling and Warnings

Capsaicin by is a Otc medication manufactured, distributed, or labeled by PHARMACURE LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient                                     Purpose

Capsaicin 0.05%                                      Topical Analgesic

PURPOSE

Uses

Temporarily relieves minor aches and pains of muscles and joints associated with arthritis, simple backache, bruises, sprains, and strains

Warnings

For external use only. Use only as directed or as directed by a health care professional.

Do not use

On wounds, cuts, damaged, or infected skin

On eyes, mouth, genitals, or any other mucous membranes

Stop use and ask a physician:

• If rash, itching, or excessive skin irritation develops.
• If conditions worsen.
• If symptoms persist for more than 7 days.
• If symptoms clear up and occur again within a few days.
• Keep out of reach of children and pets.
• If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
• Allergy Alert: If you are allergic to capsicum or chili peppers or any inactive ingredient of this product, contact a doctor before use.

When using this product

You may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.

Do not apply heat to the treated area immediately before or after use

KEEP OUT OF REACH OF CHILDREN

Directions

Adults and children 18 years of age and older: Apply 1 patch to the affected area of intact skin up to 3 times a day. Do not leave the patch on for more than 8 hours at a time.

Instructions for use:

• Clean and dry the affected area.
• Open the pouch and remove one patch.
• Remove any protective film and apply directly to the affected area of pain. Apply immediately after removal from the protective envelope.

- Wash your hands with soap and water after handling the patches.

• Reseal pouch containing unused patches after each use. Do not store the patch outside the sealed envelope.
• Fold used patches so that the adhesive side sticks to itself and safely discard used patches or pieces of cut patches where children and pets cannot get to them.

Children under 18 years: Ask a physician

Other Information

• Some individuals may not experience pain relief until several minutes or hours after applying the patch.
• Store in a cool and dry place.
• Store at 67°-77°F (19°-25° C)
• Protect the product from excessive moisture or sunlight.

Inactive ingredients

Adhesive, myrrh gum, zinc oxide

Product label

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 79643-012
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.05 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
MYRRH (UNII: JC71GJ1F3L)
ZINC OXIDE (UNII: SOI2LOH54Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 79643-012-01	10 in 1 BOX	09/01/2025
1		0.005 g in 1 PATCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	09/01/2025

Labeler - PHARMACURE LLC (055983858)