3% Menthol Plus 0.083% Capsaicin Pain Relief Patch, Package Ndc Code: 85323-008-01
3% Menthol plus 0.083% Capsaicin Pain Relief Patch, Package NDC Code: 85323-008-01
3% Menthol Plus 0.083% Capsaicin Pain Relief Patch
FDA Label NDC 85323-008
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 3% Menthol Plus 0.083% Capsaicin Pain Relief Patch (NDC 85323-008). 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 3% menthol plus 0.083% capsaicin pain relief patch, package ndc code: 85323-008-01, active ingredient, purpose, uses, warnings, 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 Ingredients (in each gram):
Menthol 30mg
Capsaicin 0.83mg
Purpose
Purpose: Topical anesthetic
Uses
Uses
Temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- bruises
- cramps
Warnings
WARNINGS: EXTERNAL USE ONLY
When using this product
- use only as directed
- do not bandage tightly or use with a heating pad
- aviod contact with eyes and mucous membranes
- do not apply to wounds or damaged skin
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- redness is present
- skin irritation develops
Stop use and ask a doctor
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.
Other Information
Other Information
- store at room temperature 68 to 77℉ (20-25℃)
Inactive Ingredients
Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Kaolin, Carbomer, Carboxymethylcellulose Sodium, Purified Water, Tartaric Acid, Povidone K90, DMDM Hydantoin, Alcohol 95%, Polysorbate 80, Propylene Glycol.
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.
Directions
DIRECTIONS
Adult and children 12 years of age and older:
- Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
- Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: DO NOT use without consulting a doctor.
Indications & Usage
Temporarily relieves minor pain associated with:
- arthritis
- simple backache
- bursitis
- tendonitis
- muscle strains
- bruises
- cramps
- Partially peel back protective film and apply exposed patch to site of pain. Carefully remove remaining film while pressing patch to skin for secure adhesions
- Apply to affected area not more than 3 to 4 times daily
Adult and children 12 years of age and older:
Children under 12 years of age: DO NOT use without consulting a doctor.
* Please review the disclaimer below.
