Your browser does not support JavaScript! ALUMINUM ACETATE ASTRINGENT (CALCIUM ACETATE AND ALUMINUM SULFATE) POWDER, FOR SOLUTION [TAGI PHARMA INCORPORATED]
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ALUMINUM ACETATE ASTRINGENT (calcium acetate and aluminum sulfate) powder, for solution
[TAGI Pharma Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Drug Facts

Active ingredient (in each packet)

Aluminum acetate

(Each powder packet, when mixed in water and ready for use, provides the active ingredient aluminum acetate resulting from the reaction of calcium acetate 839 mg and aluminum sulfate 1191 mg.)

Purpose

Astringent

Uses

temporarily relieves minor skin irritations due to:

  • poison ivy
  • poison oak
  • poison sumac
  • insect bites
  • athlete's foot
  • rashes caused by soaps, detergents, cosmetics, or jewelry

Warnings

For external use only

When using this product

  • avoid contact with eyes
  • 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • mix one, two, or three packets in 16 oz of water to obtain the following modified Burrow's Solution
Number of PacketsDilution% Aluminum acetate
one packet1:40 dilution0.14%
two packets1:20 dilution0.28%
three packets1:13 dilution0.42%
  • do not strain or filter the solution
  • can be used as a compress, wet dressing, or a soak
FOR USE AS A COMPRESS OR WET DRESSING:
  • soak a clean, soft cloth in the solution
  • apply cloth loosely to affected area for 15 to 30 minutes
  • repeat as needed or as directed by a doctor
  • discard solution after each use
FOR USE AS A SOAK:
  • soak affected area for 15 to 30 minutes as needed, or as directed by a doctor
  • repeat 3 times a day or as directed by a doctor
  • discard solution after each use

Other information

protect from excessive heat

Inactive ingredients

dextrin

Questions or comments?

1-888-EPIC-RX1

Distributed by:
TAGI Pharma
South Beloit, IL 61080

PRINCIPAL DISPLAY PANEL - 12 Powder Packets Carton

NDC 51224-153-24

ALUMINUM ACETATE
ASTRINGENT SOLUTION

Soothing, Effective Relief of Minor Skin Irritations due to:

Poison Ivy
Athlete's Foot
Insect Bites
Rashes

tagi PHARMA

Manufactured by:
Epic Pharma, LLC
Laurelton, NY 11413

Made in USA

Distributed by:
TAGI Pharma
South Beloit, IL 61080

12 POWDER PACKETS

PRINCIPAL DISPLAY PANEL - 12 Powder Packets Carton
ALUMINUM ACETATE ASTRINGENT 
calcium acetate and aluminum sulfate powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51224-153
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Acetate (Calcium Cation) Calcium Acetate839 mg  in 2030 mg
Aluminum sulfate (Aluminum Cation) Aluminum sulfate1191 mg  in 2030 mg
Inactive Ingredients
Ingredient NameStrength
icodextrin 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:51224-153-2412 in 1 CARTON
1NDC:51224-153-1212 in 1 BOX
1NDC:51224-153-992030 mg in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34706/15/2011
Labeler - TAGI Pharma Incorporated (963322560)

Revised: 06/2011
Document Id: fb7d0866-c5b6-40ac-ac3d-7903d40ac92b
Set id: 6ebed2f4-6a06-47a3-bde4-c47b32cd81cb
Version: 1
Effective Time: 20110602
 
TAGI Pharma Incorporated

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