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ZO MEDICAL SURFATROL Astringent

Dosage form: powder
Ingredients: Aluminum Acetate 4866mg in 4.866g
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-084

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

ZO® MEDICAL SURFATROL™ Astringent Powder

Drug Facts

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

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.

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.

ZO MEDICAL SURFATROL ASTRINGENT 
aluminum acetate powder
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-084
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Aluminum Acetate (Aluminum Cation) Aluminum Acetate4866 mg  in 4.866 g
Inactive Ingredients
Ingredient NameStrength
Water 
Whey 
Potassium Sorbate 
Packaging
#Item CodePackage Description
1NDC:42851-084-1910 PACKET in 1 CARTON
16 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/01/2016
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
Paramount Cosmetics001321058MANUFACTURE(42851-084)

Revised: 08/2016
 
ZO Skin Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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