FDA Label for 3% Menthol Plus 0.083% Capsaicin Pain Relief Patch

View Indications, Usage & Precautions

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
DIRECTIONS
INDICATIONS & USAGE

3% Menthol Plus 0.083% 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.

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

Active Ingredient

Active Ingredients (in each gram):

Menthol 30mg

Capsaicin 0.83mg

Purpose

Purpose: Topical anesthetic

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

Stop use and ask a doctor

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

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

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