DermacinRx Penetral Cream CAPSAICIN PURETEK CORPORATION FDA Approved Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains
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Substance Capsicum Oleoresin
Route
TOPICAL
Applications
M017

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%) Purpose Topical Analgesic
Inactive Ingredients
Inactive ingredients Acrylates Copolymer Acrylates/C10-30 Alkyl Acrylate Crosspolymer Aloe Barbadensis (Aloe Vera) Leaf Juice Aqua (Purified Water) Arnica Montana Flower Extract Ethyl Alcohol Ethyl Menthane Carboxamide Euterpe Oleracea (Acai) Fruit Oil Glycerin Hydrated Silica Hydrolyzed Corn Starch Hydrolyzed Corn Starch Octenylsuccinate Lauryl Laurate Linum Usitatissimum (Linseed) Seed Oil Mentha Piperita (Peppermint) Oil Menthyl Lactate Methyl Diisopropyl Propionamide Phenoxyethanol PPG-2 Hydroxyethyl Cocamide Rosmarinus Officinals (Rosemary) Oil Triethanolamine Zea Mays (Corn) Starch.
Strengths
0.0625 %
Treats Conditions
Uses For The Temporary Relief Of Minor Aches And Pains Of Muscles And Joints Associated With Simple Backache Arthritis Strains And Sprains

Identifiers & Packaging

Container Type UNKNOWN
UPC
0359088310083
UNII
UW86K581WY
Packaging

DermacinRx ® Penetral™ Cream Label Label

Package Descriptions
  • DermacinRx ® Penetral™ Cream Label Label

Overview

Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Indications & Usage

Uses for the temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains and sprains

Dosage & Administration

Directions Rotate pump’s spout counter-clockwise slightly to unlock; clockwise to lock. Before using on children under 18 years of age, consult a physician. Apply sparingly to affected area not more than 4 times daily. However, for first use, apply to small area to test for sensitivity or skin reaction. Gently massage into the skin until fully absorbed. Wash hands with soap and water thoroughly after each application to avoid spreading to the eyes or other sensitive mucous membranes.

Warnings & Precautions
Warnings For external use only This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns. When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help. Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use. Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.
Purpose

Purpose Topical Analgesic

Do Not Use

This is not a face cream. Do not apply to the face. Do not use if allergic to chili peppers or if past allergic reaction to capsaicin. Do not apply to wounds or damaged, broken, sunburned, chapped or irritated skin. Do not bandage tightly. Do not apply within 1 hour before or after bath, shower, hot tub, sauna or vigorous exercise. Warm water, perspiration or open pores can intensify the impact of this product and cause a burning sensation. Do not use with heating pad, hot water bottle or other source of heat. Doing so can increase risk of serious burns.

When Using

When using this product do not get into eyes and avoid contact with other mucous membranes. If contact occurs or if pain, discomfort or skin redness occurs, continually rinse with cool water and seek medical help.

Stop Use & Ask a Doctor

Discontinue use and consult a doctor if condition worsens or if symptoms persist for more than 7 days or clear up and occur again within a few days. Stop using and get immediate medical attention if experience burning, pain, swelling or blistering of the skin. Rare cases of severe burning or blistering have been reported. If pregnant, breast-feeding or any medical conditions exist, ask a health professional before use.

Keep Out of Reach of Children

Keep out of reach of children and pets. If swallowed, get medical help or contact a Poison Control Center right away. If inhaled, remove to fresh air. If breathing is difficult, get medical attention immediately.

Storage & Handling

Other information WARNING: FLAMMABLE PRODUCT Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

Questions

Questions or comments? Call toll-free 1-877-921-7873 or visit us at www.dermacinrx.com


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