FDA Label for Exact-rx Sodium Sulfacetamide Wash 10%
View Indications, Usage & Precautions
Exact-rx Sodium Sulfacetamide Wash 10% Product Label
The following document was submitted to the FDA by the labeler of this product Exact-rx, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Indications & 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 & 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.
Warnings
FOR EXTERNAL USE ONLY. NOT FOR INTRAVAGINAL OR
OPHTHALMIC USE. (KEEP AWAY FROM EYES).
KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.
In case of accidental ingestion contact a poison
control center immediately. Keep container tightly closed.
Contraindications
CONTRAINDICATIONS: Sodium Sulfacetamide 10% Wash is
contraindicated in persons with know or suspected hypersensitivity to sulfonamides.
Inactive Ingredient
Each gram contains 100 mg of sodium sulfacetamide USP in a
vehicle consisting of: citric acid, cocamidopropyl betaine, disodium EDTA,
glyceryl stearate, methylparaben, PEG-6 caprylic/capric
glycerides, PEG-60 almond glycerides, PEG-150 pentaerythrityl
tetrastearate, polysorbate 60, purified water, sodium lauryl
sulfate, sodium thiosulfate and xanthan gum.
Storage And Handling
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
Description
Manufactured in the U.S.A. for
Exact-Rx, Inc., Melville, NY 11747
Spl Patient Package Insert
SODIUM SULFACETAMIDE 10% WASH
(sodium sulfacetamide 10%)
Rx Only
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Description: Each gram contains 100 mg of sodium sulfacetamide USP in a vehicle consisting of: ammonium lauryl sulfate, butylated hydroxytoluene, ceteareth-25, cetyl alcohol, cocamidopropyl betaine, disodium EDTA, glycerin, guar gum, methylparaben, propylene glycol, propylparaben, purified water, sodium thiosulfate, stearyl alcohol, triacetin.
HOW SUPPLIED: Sodium Sulfacetamide Wash 10% is available in a 6 fl oz (170 mL) bottle, NDC 42808-101-06, and in a 12 fl oz
(354.8 mL) bottle, NDC 42808-101-12.
Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747
00-101-205-00
Iss:12/16
Package Label.Principal Display Panel
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