Capsaicin 0.03% Patch CAPSAICIN 0.03% MEDCORE LLC FDA Approved Uses For temporary relief of pain
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Substance Capsaicin
Route
TOPICAL
Applications
505G(A)(3)
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Capsaicin 0.03%
Inactive Ingredients
Inactive ingredients Poly(acrylic acid) solution Polysorbate 80 Glycerin SORBITOL Carboxymethyl Cellulose Sodium aluminium magnesium silicate PHENOXYETHANOL EDTA Disodium salt Lemon oil Water Peppermint oil.
Strengths
0.03 %
Treats Conditions
Uses For Temporary Relief Of Pain

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
S07O44R1ZM
Packaging

PRINCIPAL DISPLAY PANEL NDC: 82461- 418-10 Medcore LLC Capsaicin 0.03% Pain Relieving Hydrogel Technology Contains: 10 Patches Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920 Store in a dry, cool place. For Comments or Questions, call 908-280-2269 Capsaicin

Package Descriptions
  • PRINCIPAL DISPLAY PANEL NDC: 82461- 418-10 Medcore LLC Capsaicin 0.03% Pain Relieving Hydrogel Technology Contains: 10 Patches Manufactured for: Medcore LLC 3048 Valley Rd Basking Ridge, NJ 07920 Store in a dry, cool place. For Comments or Questions, call 908-280-2269 Capsaicin

Overview

Uses For temporary relief of pain

Indications & Usage

Uses For temporary relief of pain

Dosage & Administration

Directions Adult and children 12 years of age and over : clean and dry affected area 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

Warnings & Precautions
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 When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly Stop use and ask a doctor if 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 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.
Purpose

Purpose Topical analgesic

Do Not Use

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

When Using

When using this product use only as directed avoid contact with the eyes, mucous membranes or rashes do not bandage tightly

Stop Use & Ask a Doctor

Stop use and ask a doctor if 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

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.

Storage & Handling

Other information Store at room temperature 15°-30°C (59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.


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