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DermasilkRx DicloPak

Approved
Approval ID

1cac4fd0-70cb-2bbf-e054-00144ff8d46c

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 7, 2015

Manufacturers
FDA

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
NDC Product Code69329-335
Application NumberANDA074514
Product Classification
M
Marketing Category
C73584
G
Generic Name
diclofenac sodium delayed release tablets, capsaicin cream
Product Specifications
Effective DateAugust 7, 2015
FDA Product Classification

Drug Labeling Information

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/9/2015

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

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DermasilkRx DicloPak - FDA Drug Approval Details