Entty Spray Emulsion by Burke Therapeutics, LLC ENTTY SPRAY EMULSION-

Entty Spray Emulsion by

Drug Labeling and Warnings

Entty Spray Emulsion by is a Other medication manufactured, distributed, or labeled by Burke Therapeutics, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 250 mL spray bottle.

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

STORAGE AND HANDLING

STORE AT ROOM TEMPERATURE

SHAKE WELL BEFORE USING

SPL UNCLASSIFIED SECTION

Distributed in the U.S.A. by:
Burke Therapeutics
Hot Springs, AR 71913
Manufactured by: bioTD S.A., Heredia, Costa Rica www.bio-td.com

FDA approval: K141637

Container Label

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

INGREDIENTS AND APPEARANCE

ENTTY SPRAY EMULSION 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:69101-090

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:69101-090-01	250 mL in 1 BOTTLE, SPRAY; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)

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)