Foraxa Rx Skin Emulsion: Package Insert and Label Information

FORAXA RX SKIN EMULSION-
Sterling-Knight Pharmaceuticals, LLC

DESCRIPTION

Foraxa Rx Emulsion is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

INDICATIONS & USAGE

Foraxa Rx Skin Emulsion is indicated as a prescription topical skin care emulsion for the management of painful wounds. Foraxa Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

Directions: Apply a small amount of Foraxa Rx Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

WARNINGS

External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

PRECAUTIONS:

Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
Call your doctor about side effects. You may report side effects to Sterling Knight Pharmaceuticals, LLC at 1-888-460-1531 or the FDA at 1-800-FDA-1088.

INSTRUCTIONS FOR USE

Apply a small amount of Foraxa Rx Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

INGREDIENTS

Water, Collagen, Aloe Vera gel, Lidocaine Hydrochloride, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

HOW SUPPLIED

Foraxa Rx Emulsion is supplied in:
28g tube, NDC 69336-812-28

Distributed By:

Sterling-Knight Pharmaceuticals, LLC
Ripley, MS 38663
Rev 082019-1

STORAGE:

Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

foraxa
(click image for full-size original)

FORAXA RX SKIN EMULSION
Product Information
Product Type Item Code (Source) NHRIC:69336-812
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:69336-812-28 28 g in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K020540 09/17/2018
Labeler — Sterling-Knight Pharmaceuticals, LLC (079556942)

Revised: 11/2019 Sterling-Knight Pharmaceuticals, LLC

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