DermasilkRx DicloPak
1cac4fd0-70cb-2bbf-e054-00144ff8d46c
HUMAN PRESCRIPTION DRUG LABEL
Aug 7, 2015
Patchwerx Labs, Inc.
DUNS: 079584480
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac sodium delayed release tablets, capsaicin cream
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
Drug Labeling Information
SPL UNCLASSIFIED SECTION
DermaSilkRx Penetral Cream
Drug Facts
Active ingredient
Capsicum Oleoresin 0.0625% (containing capsaicin 0.025%)
Purpose
Topical Analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, strains, and sprains.
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 product immediately and get medical attention if experiencing 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.
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.
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, Ethylhexylglycerin, Euterpe Oleracea (Acai) Fruit Oil, Glycerin, Hydroxyethyl Behenamidopropyl Dimonium Chloride, Lauryl Laurate, Linum Usitatissimum (Flax) Seed Oil, Mentha Piperita (Peppermint) Oil, Menthyl Lactate, Methyl Diisopropyl Propionamide, Phenoxyethanol, PPG-2 Hydroxyethyl Cocamide, Rosmarinus Officinals (Rosemary) Oil, Triethanolamine.
Questions or comments?
Call toll-free 1-800-317-2910 or visit us at www.dermasilkrx.com