Hylaguard Cream by Lacer Pharma LLC HYLAGUARD CREAM-

Hylaguard Cream by

Drug Labeling and Warnings

Hylaguard Cream by is a Other medication manufactured, distributed, or labeled by Lacer Pharma LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Indications for Use

Under the supervision of a healthcare professional, Hylaguard Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Hylaguard Cream also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

Device Description

Hylaguard Cream is a non-sterile, white to off-white, low odor, fragrance free, topical product. The Hylaguard Cream forms a physical barrier that helps to maintain a moist wound and skin environment. Hylaguard Cream is a prescription device.

Contraindications

Hylaguard Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Warnings

Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

Precautions and Observations

• Hylaguard Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun.
• If clinical signs of infection are present, appropriate treatment should be initiated; use of Hylaguard Cream may be continued during the anti-infective therapy.
• If the condition does not improve within 10-14 days, consult a physician.
• Hylaguard Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

Instructions for Use

Dispense Hylaguard Cream into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing. Hylaguard Cream is non-sterile.

Ingredients

Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Methylparaben, Disodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

How Supplied

Hylaguard Cream is available in 450g commercial jars. 450g jar may be used for up to 60 days after opening.

CAUTION: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

Store between 59°F - 86°F (15°C - 30°C).

Hylaguard Cream Net Weight: 450g

INGREDIENTS AND APPEARANCE

HYLAGUARD CREAM 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	GS1:860003564905

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	GS1:860003564905	1 in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K150914	05/15/2020

Labeler - Lacer Pharma LLC (117072266)