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NDC 51224-0153-24 Aluminum Acetate Astringent 1191; 839 mg/2030mg; mg/2030mg Details

Aluminum Acetate Astringent 1191; 839 mg/2030mg; mg/2030mg

Aluminum Acetate Astringent is a TOPICAL POWDER, FOR SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by TAGI Pharma Incorporated. The primary component is ALUMINUM SULFATE; CALCIUM ACETATE.

Product Information

NDC	51224-0153
Product ID	51224-153_a4b9d3a3-fe12-4313-922f-abc93f440e6c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Aluminum Acetate Astringent
Proprietary Name Suffix	n/a
Non-Proprietary Name	Calcium Acetate and Aluminum sulfate
Product Type	HUMAN OTC DRUG
Dosage Form	POWDER, FOR SOLUTION
Route	TOPICAL
Active Ingredient Strength	1191; 839
Active Ingredient Units	mg/2030mg; mg/2030mg
Substance Name	ALUMINUM SULFATE; CALCIUM ACETATE
Labeler Name	TAGI Pharma Incorporated
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part347
Listing Certified Through	2022-12-31

Package

Package Images

NDC 51224-0153-24 (51224015324)

Pricing Information	N/A
NDC Package Code	51224-153-24
Billing NDC	51224015324
Package	12 BOX in 1 CARTON (51224-153-24) / 12 POUCH in 1 BOX (51224-153-12) / 2030 mg in 1 POUCH (51224-153-99)
Marketing Start Date	2011-06-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6ebed2f4-6a06-47a3-bde4-c47b32cd81cb Details

SPL UNCLASSIFIED SECTION

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 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%

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Calcium Acetate (UNII: Y882YXF34X) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Acetate	839 mg in 2030 mg
Aluminum sulfate (UNII: 34S289N54E) (Aluminum sulfate anhydrous - UNII:I7T908772F)	Aluminum sulfate	1191 mg in 2030 mg

Ingredient Name	Strength
Inactive Ingredients
icodextrin (UNII: 2NX48Z0A9G)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:51224-153-24	12 in 1 CARTON	06/15/2011
1	NDC:51224-153-12	12 in 1 BOX
1	NDC:51224-153-99	2030 mg in 1 POUCH; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part347	06/15/2011

Labeler - TAGI Pharma Incorporated (963322560)

Revised: 11/2018

Document Id: a4b9d3a3-fe12-4313-922f-abc93f440e6c

Set id: 6ebed2f4-6a06-47a3-bde4-c47b32cd81cb

Version: 2

Effective Time: 20181120

Search by Drug Name or NDC

NDC 51224-0153-24 Aluminum Acetate Astringent 1191; 839 mg/2030mg; mg/2030mg Details

Aluminum Acetate Astringent 1191; 839 mg/2030mg; mg/2030mg

Product Information

Package

Package Images

NDC 51224-0153-24 (51224015324)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 6ebed2f4-6a06-47a3-bde4-c47b32cd81cb Details

SPL UNCLASSIFIED SECTION

Active ingredient (in each packet)

Purpose

Uses

Warnings

When using this product

Directions

Other information

Inactive ingredients

Questions or comments?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - 12 Powder Packets Carton

INGREDIENTS AND APPEARANCE

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