FDA Label for 0.025% Capsaicin Pain Relief Patch
View Indications, Usage & Precautions
0.025% Capsaicin Pain Relief Patch Product Label
The following document was submitted to the FDA by the labeler of this product Xuzhou Lanting Pharmaceutical Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323-001-00
0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-001-00
Active Ingredient
Active Ingredient: 0.025% Capsaicin
Purpose
Purpose: Topical anesthetic
Warnings
Warnings (For external use only)
- Do not use
- more than 1 patch at a time
- on wounds or damaged skin
- with a heating pad
- if you are allergic to any ingredients of this product
- use only as directed
- avoid contact with the eyes, mucous membranes or rashes
- do not bandage tightly
- localized skin reactions occur, such as rash, itching, redness, irritation, pain, swelling and blistering
- condition worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within a few days
When using this product
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Uses For temporary relief of minor aches & pains of muscles & joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Glycerin, dihydroxyaluminum aminoacetate anhydrous, edetate disodium, tartaric acid, povidone K90, dmdm hydantoin, polysorbate 80, propylene glycol, carboxymethylcellulose sodium, kaolin, carbomer, sodium polyacrylate, water.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Uses For temporary relief of minor aches & pains of muscles & joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour apolication
Children under 12 years of age: consult a doctor
Dosage & Administration
Adult and children 12 years of age and over:
clean and dry affected area
remove film from patch and apply to the skin (see illustration)
apply 1 patch at a time to affected area, not more than 3 to 4 times daily
remove patch from the skin after at most 8-hour application
Children under 12 years of age: consult a doctor
* Please review the disclaimer below.
