ZO MEDICAL SURFATROL ASTRINGENT- aluminum acetate powder

ZO MEDICAL SURFATROL Astringent by

Drug Labeling and Warnings

ZO MEDICAL SURFATROL Astringent by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Paramount Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purpose
* When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions
Aluminum Sulfate Tetradecahydrate, 2850 mg	Astringent*
Calcium Acetate Monohydrate, 2016 mg	Astringent*

Uses

For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Warnings

For external use only

When using this product

• avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• do not cover compress or wet dressing with plastic to prevent evaporation
• in some skin conditions, soaking too long may overdry

Stop use and ask a doctor if

• condition worsens or symptoms persist for more than 7 days

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• dissolve 1 packet in 12 oz. of cool or warm water.
• stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.45% aluminum acetate and is ready for use.

For use as a compress or wet dressing:

• dip clean gauze in the solution
• apply gauze loosely to affected area for 1 to 2 minutes
• repeat 3-4 times a day as needed or as directed by a doctor
• discard solution after each use

Other information

• Store at a comfortable temperature range indoors, usually considered to be 68 to 77°F (20 to 25°C).
• Avoid storing at extreme temperatures above 104°F (40°C).

Inactive ingredients

Water, Dextrin, Avena Sativa (Oat) Kernel Protein, Glycine Soja (Soybean) Protein, Whey Protein, Potassium Sorbate, Chitosan.

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DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 6 g Packet Carton

ZO®MEDICAL
BY ZEIN OBAGI MD

NDC: 42851-084-19

SURFATROL™
Astringent Solution
Powder

10 ea. Net Wt. 6 g / 0.21 Oz.

INGREDIENTS AND APPEARANCE

ZO MEDICAL SURFATROL ASTRINGENT 
aluminum acetate powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-084
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Aluminum Acetate (UNII: 80EHD8I43D) (Aluminum Cation - UNII:3XHB1D032B)	Aluminum Acetate	4866 mg  in 4.866 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Whey (UNII: 8617Z5FMF6)
Potassium Sorbate (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-084-19	10 in 1 CARTON	08/01/2016
1		6 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Paramount Cosmetics		001321058	MANUFACTURE(42851-084)