0.025% Capsaicin Pain Relief Patch, Package Ndc Code: 85323-005-01
0.025% Capsaicin Pain relief Patch, Package NDC Code: 85323-005-01
0.025% Capsaicin Pain Relief Patch
FDA Label NDC 85323-005
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 85323-005). 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: 85323-005-01, 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
- 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
- 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
- rash, itching or excessive skin irritation develops
- condition worsen
- symptoms persist for more than 7 days
- symptoms clear up and occur again within 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 (1-800-222-1222) immediately.
Uses
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
Other Information
Other Information
- Avoid storing product in direct sunlight
- Protect product from excessive moisture
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Propylene Glycol, Polysorbate 80, Carboxymethylcellulose Sodium, Carbomer, Purified Water, POVIDONE K90, Tartaric Acid, Dmdm Hydantoin.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.
Indications & Usage
For temporary relief of minor aches and pains of muscles & joints associated with:
- Simple Backache
- Arthritis
- Strains
- Bruises
- Sprains
- 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
Adult and children 12 years of age and over:
Children under 12 years of age: consult a doctor.
Directions
Adult 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.
* Please review the disclaimer below.
