Hylinate by Artesa Labs, LLC Hylinate Lotion

Drug Details [pdf]

HYLINATE- hyaluronate sodium lotion
Artesa Labs, LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Hylinate Lotion

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

DESCRIPTION

Each mL contains 1 mg of sodium hyaluronate, carbomer 980, imidazolidinyl urea, methylparaben, propylparaben, purified water, and triethanolamine.

INDICATIONS

This product is indicated in the treatment of symptoms associated with xerosis (dry, scaly skin).

CONTRAINDICATIONS

This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.

WARNINGS

KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

General: This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.

Information for Patients: Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.

Pregnancy: Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers: It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

ADVERSE REACTIONS

If any adverse reaction occurs, discontinue use and seek the attention of a physician.

DOSAGE AND ADMINISTRATION

Apply to the affected area(s) and rub in thoroughly. Use a liberal amount two to three times daily or as directed by a physician.

STORAGE

Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat. Keep container tightly closed.

HOW SUPPLIED

This product is supplied in the following size(s):
12 fl. oz. (340 mL) bottles, NDC: 57893-314-12

To report a serious adverse event or obtain product information, call 1-855-899-4237.

Manufactured for:
Artesa Labs, LLC
13785 Research Blvd.
Suite 125
Austin, TX 78750

1900293 [00] Rev. 01/2020

HYLINATE
hyaluronate sodium lotion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 57893-314
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY)	HYALURONATE SODIUM	1 mg in 1 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 57893-314-12	340 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2020	03/30/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved drug other		01/13/2020	03/30/2020

Labeler - Artesa Labs, LLC (078786339)

Revised: 3/2020

Document Id: a2157f27-e59d-400b-e053-2995a90a83e5

Set id: 9c0af50f-0f2f-cc8c-e053-2995a90ab2f6

Version: 2

Effective Time: 20200330