SPL v17
SPL
SPL Set ID ab24cced-1224-492e-8c31-74c9388050bf
Route
TOPICAL
Published
Effective Date 2023-10-23
Document Type 34391-3 HUMAN PRESCRIPTION DRUG LABEL

Drug Facts

Composition & Product

Identifiers & Packaging


Description

INDICATIONS : Sodium Sulfacetemide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatisis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.


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% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatisis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Dosage and Administration

DIRECTIONS FOR USE : Wash affected areas twice daily (morning and evening) or as directed by your physician. Rinse thoroughly and pat dry. See package insert for complete product information .

Contraindications

CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated in persons with know or suspected hypersensitivity to sulfonamides.

Description

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

Section 44425-7

Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F). See USP Controlled Room. Protect from freezing. See bottle for lot number and expiration date

Section 51727-6

3

Section 51945-4

2


Structured Label Content

Indications and Usage (34067-9)

INDICATIONS : Sodium Sulfacetemide 10% Wash is intended for topical application in the following scaling dermatoses: seborrheic dermatisis and seborrhea sicca (dandruff). It also is indicated for the treatment of secondary bacterial infections of the skin due to organisms susceptible to sulfonamides.

Dosage and Administration (34068-7)

DIRECTIONS FOR USE : Wash affected areas twice daily (morning and evening) or as directed by your physician. Rinse thoroughly and pat dry. See package insert for complete product information .

Contraindications (34070-3)

CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is contraindicated in persons with know or suspected hypersensitivity to sulfonamides.

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 44425-7 (44425-7)

Store at 25C (77F); excursions permitted to 15 to 30C (59 to 86F). See USP Controlled Room. Protect from freezing. See bottle for lot number and expiration date

Section 51727-6 (51727-6)

3

Section 51945-4 (51945-4)

2


Raw Label Data

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