0.025% Capsaicin Pain Relief Patch
FDA Label NDC 85323-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Xuzhou Lanting Pharmaceutical Co., Ltd for the product 0.025% Capsaicin Pain Relief Patch (NDC 85323-001). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding 0.025% capsaicin pain relief patch, package ndc code: 85323-001-00, active ingredient, purpose, warnings, uses, other information, inactive ingredients, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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.
