Capsaicin by PHARMACURE, INC. CAPSAICIN patch

Capsaicin by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredient

Capsaicin 0.025%

Purpose

Topical Anesthetic

Uses

Temporarily relieves mild to moderate aches and pains of muscles and joints associated with muscle soreness, strains, sprains, arthritis, simple backache, muscle stiffness, bruises.

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.

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.

Avoid contact with the eyes, lips, nose and mucous membranes.

Do not tightly wrap or bandage the treated area.

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

Stop use and ask a physician:

rash, itching or excessive skin irritation develops.
conditions worsen.
symptoms persist for more than 7 days.
symptoms clear up and occur again within a few days.

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

Keep out of reach of children and pets

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

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 patch on for more than 8 hours at a time.

 INSTRUCTIONS FOR USE :

Clean and dry the affected area.

  Open pouch and remove one patch.

  Remove any protective film and apply directly to affected area of pain. Apply immediately after removal from the protective envelope.

Wash hands with soap and water after handling the patches.

  Reseal pouch containing unused patches after each use. Do not store patch outside the sealed envelope.

Discontinue use at least one hour prior to bath, shower, or swimming; do not use immediately after bath, shower, or swimming.

  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

Inactive ingredients

Adhesive, myrrh gum, zinc oxide.

Other information

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

Label

INGREDIENTS AND APPEARANCE

CAPSAICIN 
capsaicin patch

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 79643-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM)	CAPSAICIN	0.025 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: 79643-002-01	10 in 1 BOX	02/02/2021
1		100 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
unapproved drug other		02/02/2021

Labeler - PHARMACURE LLC (055983858)