Exact-rx Sodium Sulfacetamide And Sulfur 10%/5% Cleanser

Exact-rx Sodium Sulfacetamide And Sulfur 10%/5% Cleanser
SPL v13
SPL
SPL Set ID bbacc6fe-5627-4126-b26d-2a550d304f8e
Route
TOPICAL
Published
Effective Date 2020-05-19
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

INDICATIONS : Sodium Sulfacetemide 10% and Sulfer 5% Cleanser is indicated for he topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES) .

Indications and Usage

INDICATIONS : Sodium Sulfacetemide 10% and Sulfer 5% Cleanser is indicated for he topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage and Administration

DIRECTIONS FOR USE : Wash affected area once or twice daily, or as directed by your physician. Avoid contat with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. if drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. See package insert for complete product information .

Contraindications

CONTRAINDICATIONS : Sodium Sulfacetamide 10% & Sulfer 5% Cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5% Cleanser is not to be used by patients with kidney disease. CAUTION : If redness or irritaiton occurs, discontinue use.

Description

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Section 42230-3

4

Section 44425-7

Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing. See bottle for lot number and expiration date

Section 51727-6

7

Section 51945-4

5


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS : Sodium Sulfacetemide 10% and Sulfer 5% Cleanser is indicated for he topical control of acne vulgaris, acne rosacea and seborrheic dermatitis.

Dosage and Administration (34068-7)

DIRECTIONS FOR USE : Wash affected area once or twice daily, or as directed by your physician. Avoid contat with eyes or mucous membranes. Wet skin and liberally apply to areas to be cleansed, massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry. if drying occurs, it may be controlled by rinsing cleanser off sooner or using less often. See package insert for complete product information .

Contraindications (34070-3)

CONTRAINDICATIONS : Sodium Sulfacetamide 10% & Sulfer 5% Cleanser is contraindicated in persons with know or suspected hypersensitivity to sulfonamides, sulfer or any other component of this preparation. Sodium Sulfacetamide 10% & Sulfer %5% Cleanser is not to be used by patients with kidney disease. CAUTION : If redness or irritaiton occurs, discontinue use.

Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR OPHTHALMIC USE. (KEEP AWAY FROM EYES) .

Description (34089-3)

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

Section 42230-3 (42230-3)

4

Section 44425-7 (44425-7)

Store at 20 to 25C (68 to 77F). See USP Controlled Room Temperature. Protect from freezing. See bottle for lot number and expiration date

Section 51727-6 (51727-6)

7

Section 51945-4 (51945-4)

5


Raw Label Data

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