Kivik Rx Skin Emulsion: Package Insert and Label Information

KIVIK RX SKIN EMULSION-
Phlight Pharma

DESCRIPTION

Kivik Rx Skin Emulsion is a water-based topical skin care emulsion that is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. Kivik Rx Skin Emulsion contains natural extracts to moisturize the skin.

INDICATIONS FOR USE

Kivik Rx Skin Emulsion is indicated as a prescription topical skin care emulsion to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic and allergic contact dermatitis. Kivik Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

Kivik Rx Skin Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

PRECAUTIONS

Kivik Rx Skin Emulsion is for external use only.
Product should not be used prior to MRI Imaging, as it contains silver nanoparticles that can cause heating during these procedures.
Kivik Rx Skin Emulsion does not contain sunscreen. If the condition does not improve within 10 days, consult a physician. If clinical signs of infection are present, appropriate treatment should be initiated; use of Kivik Rx Skin Emulsion may be continued during anti-infective therapy.
Keep this and other similar products out of the reach of children.

HOW TO APPLY

Shake well before use. Apply a small amount of Kivik Rx Skin 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

Kivik Rx Skin Emulsion contains deionized water, copolymer, vegetable oils from African palms, and silver nanoparticles (as a preservative), and benzoyl peroxide (less than 1%).

HOW SUPPLIED

Kivik Rx Skin Emulsion is available in 60mL bottles, 70569-027-02.

Shake well before using.
Store at room temperature. Do not freeze.

Rx Only

For External Use Only.

PRESCRIPTION MEDICAL DEVICE:FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN

Manufactured for:

Phlight Pharma
998 Robinson St. Ste B
Ocean Springs, MS 39564

KIVIK RX SKIN EMULSION LABEL

Kivik Label
(click image for full-size original)

KIVIK RX SKIN EMULSION
Product Information
Product Type Item Code (Source) NHRIC:70569-027
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:70569-027-02 60 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K141637 08/28/2019
Labeler — Phlight Pharma (080168751)

Revised: 08/2019 Phlight Pharma

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