Hydro 35 aerosol, foam

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For Topical Dermatological Use Only

Rx Only - Caution: Federal Law restricts this product to sale by, or on the order of a licensed healthcare practitioner.

Description

HYDRO 35 Foam is a keratolytic agent delivered in a water & lipid based emollient foam containing lactic acid. This foam gently softens excess tissue to enhance removal from skin and nails, while rehydrating healthy tissue. Each gram contains 35% Urea as the active ingredient.

CHEMICAL STRUCTURE Chemical Structure
Urea has the following chemical structure:

Clinical pharmacology

Topically applied urea dissolves the intercellular matrix of the skin which results in softening of the hyperkeratotic tissue, and thus enhances shedding of scaly, dry skin. Urea topically applied to the nail plate has a similar effect on the intercellular matrix of the nail plate.

Pharmacokinetics

The mechanism of action of topical urea is not yet known.

Indications for use

For enzyme debridernent and promotion of normal healing of surface lesions, particularly where healing is retarded by local infection. Necrotic tissue. fibrinous or purulent debris. Or eschar. Topically applied urea is useful for the treatment of hyperkeratotic conditions such as dermatitis. psoriasis, xerosis.ichthyosis, eczema.keratosis.keratoderma, and dry, rough skin, as well as corns and calluses and damaged, ingrown and devitalized nails.

Contraindications

HYDRO 35 Foam should not be used by persons who have a known hypersensitivity to urea or any of the listed ingredients.

Warnings

For external use only. Not for ophthalmic, oral,and or intravaginal use. Avoid contact with the eyes, lips, and other mucous membranes.

KEEP THIS AND OTHER MEDICATIONS OUT OF THE REACH OF CHILDREN.

Contains flammable materials. Contents under pressure. Do not puncture or incinerate. Do not expose to temperatures over 120'F (48'C) even when empty.

Precautions

Use only as directed by a healthcare practitioner. Do not use to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and contact prescribing healthcare practitioner.

Pregnancy (category c)

Animal reproduction studies have not been conducted with Hydro 35 Foam. It is also not known whether Hydro 35 Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Hydro 35 Foam should be given to a pregnant woman only if clearly needed.

Nursing mothers

It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering HYDRO 35 Foam to nursing mothers.

Dosage and administration

Apply to affected area twice a day unless otherwise directed by a prescribing healthcare practitioner. HYDRO 35 Foam should be rubbed gently into the skin until it is completely absorbed.

Follow these important directions to ensure proper foaming and maximum delivery of product:

  • Shake canister vigorously before each use.
  • Tum upside down (nozzle down) to dispense.
  • Depress ridged portion of dispenser, as illustrated at right.
Hydro 35

Ingredients

Urea 35%, dimethicone, ethylparaben. Glycerin, Lactic acid, methyl paraben, phenoxyethanol, polysorbate 20.povidone, propylene glycol. propylparaben, purified water, Stearic acid, trolamine, and as propellants isobutane and propane.

How supplied

HYDRO 35 Foam is supplied in a 5.3 ounce (150g) pressurized canister bearing the NDC Number 23710-035-15 and i n a 0.79 ounce (22g) pressurized canister bearing the NDC Number 23710-035-20.

Storage and handling section

Store at controlled room temperature 15 to 25c (59 to 77F).

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US Patent 5,993.830

Manufactured in the USA for
Exeltis USA Dermatology, LLC
Florham Park, NJ 07932

www.exeltisUSA.com
© 2012 Exeltis USA Dermatology, LLC

Rev 09/2015
51000020

Ingredients and appearance - Product information

Hydro 35 aerosol, foam- Urea in a water and lipid based foam containing lactic acid

Product information

Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC: 23710-035
Route of Administration Topical

Active Ingredient/Active Moiety

Ingredient Name Strength
Urea ( UNII: 8W8T17847W)( Urea - UNII: 8W8T17847W ) 35 gin 100 g

Inactive Ingredients

Ingredient Name Code
Dimethicone ( UNII: 92RU3N3Y1O)
Ethylparaben ( UNII: 14255EXE39)
Glycerin ( UNII: PDC6A3C0OX)
Lactic acid, unspecified form ( UNII: 33X04XA5AT)
Methylparaben ( UNII: A2I8C7HI9T)
Phenoxyethanol ( UNII: HIE492ZZ3T)
Polysorbate 20 ( UNII: 7T1F30V5YH)
Povidones ( UNII: FZ989GH94E)
Propylene glycol ( UNII: 6DC9Q167V3)
Propylparaben ( UNII: Z8IX2SC1OH)
Water ( UNII: 059QF0KO0R)
Stearic acid ( UNII: 4ELV7Z65AP)
Trolamine ( UNII: 9O3K93S3TK)
Butane ( UNII: 6LV4FOR43R)
Propane ( UNII: T75W9911L6)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
Unapproved drug other USA

Labeler - Exeltis USA Dermatology, LLC( 078715346)

Establishment

Name ID/FEI Business Operations
Exeltis USA Dermatology, LLC 078715346 MANUFACTURE( 23710-035), LABEL( 23710-035)

Principal display panel - 150 g canister label

NDC 23710-035-15

HYDRO 35 ®
35% UREA IN A VEHICLE
CONTAINING LACTIC ACID

HYDRATING TOPICAL FOAM

PRODERM TECHNOLOGY ®

Rx Only
NET WT. 5.3 OZ (150 g)

Principal display panel - 150 g canister carton

NDC 23710-035-15

HYDRO 35 ®
35% UREA IN A VEHICLE
CONTAINING LACTIC ACID

HYDRATING TOPICAL FOAM
PRODERM TECHNOLOGY ®

Rx Only
NET WT. 5.3 OZ (150 g)