ALUMINUM ACETATE ASTRINGENT- calcium acetate and aluminum sulfate powder, for solution 
TAGI Pharma Incorporated

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.

----------

ALUMINUM ACETATE
ASTRINGENT SOLUTION

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:

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

Number of Packets Dilution % Aluminum acetate
one packet 1:40 dilution 0.14%
two packets 1:20 dilution 0.28%
three packets 1:13 dilution 0.42%
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 Type HUMAN OTC DRUG Item Code (Source) NDC:51224-153
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Calcium Acetate (UNII: Y882YXF34X) (Calcium Cation - UNII:2M83C4R6ZB) Calcium Acetate 839 mg  in 2030 mg
Aluminum sulfate (UNII: 34S289N54E) (Aluminum Cation - UNII:3XHB1D032B) Aluminum sulfate 1191 mg  in 2030 mg
Inactive Ingredients
Ingredient Name Strength
icodextrin (UNII: 2NX48Z0A9G)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:51224-153-24 12 in 1 CARTON
1 NDC:51224-153-12 12 in 1 BOX
1 NDC:51224-153-99 2030 mg in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 06/15/2011
Labeler - TAGI Pharma Incorporated (963322560)

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