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

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Calcium Acetate (UNII: Y882YXF34X) (Calcium Cation - UNII:2M83C4R6ZB), Aluminum sulfate (UNII: 34S289N54E) (Aluminum sulfate anhydrous - UNII:I7T908772F)

Available from:

TAGI Pharma Incorporated

INN (International Name):

Calcium Acetate

Composition:

Calcium Acetate 839 mg in 2030 mg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Astringent 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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
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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.)
PURPOS E
Astringent
US ES
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 O