Drug Facts

ALUMINUM ACETATE ASTRINGENT- calcium acetate and aluminum sulfate powder, for solution 
Epic Pharma, LLC

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.

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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 packet1:20 dilution0.28%
three packet1:13 dilution0.42%
  • do not strain or filter the solution
  • can be used as a compress, wet dressing, or 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 of comments?

1-888-EPIC-RX1

Manufactured by:

Epic Pharma, LLC

Laurelton, NY 11413

Package/Label Principal Display Panel - Packet

Aluminum Acetate Astringent Solution Pouch, LE1490,  ISS 5/10

Package/Label Principal Display Panel - 12 Packet Carton

Aluminum Acetate Astringent Solution Carton, 12 Packets, LE1497, ISS 5/10
ALUMINUM ACETATE ASTRINGENT 
aluminum acetate astringent powder, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42806-106
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 SULFATE ANHYDROUS) ALUMINUM SULFATE1191 mg  in 2030 mg
Inactive Ingredients
Ingredient NameStrength
MALTODEXTRIN 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:42806-106-4412 in 1 BOX
1NDC:42806-106-2412 in 1 CARTON
1NDC:42806-106-992030 mg in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/28/201104/30/2013
Labeler - Epic Pharma, LLC (827915443)

Revised: 02/2013
 
Epic Pharma, LLC