Penetral Cream

Penetral Cream
SPL v6
SPL
SPL Set ID 1e343a52-6071-3230-e054-00144ff8d46c
Route
TOPICAL
Published
Effective Date 2015-08-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Inactive Ingredients
Starch, Corn Hydroxyethyl Behenamidopropyl Dimonium Chloride Lauryl Laurate Trolamine Methacrylic Acid - Ethyl Acrylate Copolymer (1:1) Type A Water Aloe Vera Leaf Arnica Montana Flower Alcohol Ethyl Menthane Carboxamide Acai Oil Hydrated Silica Glycerin Corn Syrup Peppermint Oil Menthyl Lactate, (-)- Methyl Diisopropyl Propionamide Phenoxyethanol Ppg-2 Hydroxyethyl Cocamide Rosemary Oil Carbomer Interpolymer Type A (55000 Cps) Octenylsuccinic Anhydride Amylopectin, Unspecified Source Linseed Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-06-09

Description

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Uses

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

Section 50570-1
  • 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.
Warnings

For external use only

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.
Dermacinrx ®

Active Ingredient

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

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.

Questions Or Comments?

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

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.


Structured Label Content

Uses

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

Section 50570-1 (50570-1)
  • 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.
Purpose

Topical Analgesic

Warnings

For external use only

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.
Dermacinrx ® (DermacinRx ®)

Active Ingredient (Active ingredient)

Capsicum Oleoresin 0.0625% (Containing Capsaicin 0.025%)

Other Information (Other information)

WARNING: FLAMMABLE PRODUCT

Store in a cool well ventilated area away from heat. Keep away from sparks or open flame.

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.

Questions Or Comments? (Questions or comments?)

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

When Using This Product (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 (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. (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.


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