Entty Spray Emulsion: Package Insert and Label Information

ENTTY SPRAY EMULSION-
Burke Therapeutics, LLC

DESCRIPTION

Entty Spray 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.

Entty Spray Emulsion contains natural extracts to moisturize the skin.

INDICATIONS & USAGE

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. Entty Spray Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

Entty Spray Emulsion is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

PRECAUTIONS

Entty Spray 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.

Entty Spray 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 Entty Spray Emulsion may be continued during anti-infective therapy.

Keep this and other similar products out of the reach of children.

DIRECTIONS FOR USE

Spray a small amount of Entty Spray 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

De-ionized water, copolymer, sodium hyaluronate in vegetable oils from African palms and silver nanoparticles (as a preservative).

HOW SUPPLIED

Entty® Spray Emulsion is available in a 90 mL spray bottle, (NDC 69101-090-02), and a 250 mL spray bottle (NDC 69101-090-01).

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

STORE AT ROOM TEMPERATURE

SHAKE WELL BEFORE USING

Distributed in the U.S.A. by:
Burke Therapeutics
Hot Springs, AR 71913
Manufactured by: Laboratorios Zepol S.A. Costa Rica

FDA approval: K141637

Container Label

Entty® Spray Emulsion 250 mL
(click image for full-size original)

Entty® Spray Emulsion 250 mL (NDC 69101-090-01)
For Topical Dermatological Use only.
Rx Only

Container Label

Entty® Spray Emulsion 90 mL label
(click image for full-size original)

Entty® Spray Emulsion 90 mL Label (NDC 69101-090-02)
For Topical Dermatological Use only.
Rx Only

Carton Label

Entty® Spray Emulsion 90 mL carton
(click image for full-size original)

Entty® Spray Emulsion 90 mL Carton (NDC 69101-090-02)
For Topical Dermatological Use only.
Rx Only

ENTTY SPRAY EMULSION
Product Information
Product Type Item Code (Source) NHRIC:69101-090
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:69101-090-01 250 mL in 1 BOTTLE, SPRAY None
2 NHRIC:69101-090-02 1 BOTTLE, SPRAY in 1 CARTON contains a BOTTLE, SPRAY
2 90 mL in 1 BOTTLE, SPRAY This package is contained within the CARTON (69101-090-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
premarket notification K141637 02/02/2018
Labeler — Burke Therapeutics, LLC (079259903)

Revised: 10/2020 Burke Therapeutics, LLC

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