SPL v5
SPL
SPL Set ID 065c895c-7d86-f1ed-e063-6394a90a3a52
Route
TOPICAL
Published
Effective Date 2023-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Cation (952 mg) Aluminum Cation (1347 mg)
Inactive Ingredients
Icodextrin

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-27

Description

Active Ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent* Calcium acetate monohydrate, 952 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.


Medication Information

Warnings and Precautions

FOR EXTERNAL USE ONLY

Indications and Usage

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
Dosage and Administration

Directions

  • Dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water.
  • Stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3packets) aluminum acetate and is ready for 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.

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.
Description

Active Ingredients (in each packet) Purpose Aluminum sulfate tetradecahydrate, 1347 mg Astringent* Calcium acetate monohydrate, 952 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions.

Section 44425-7

Protect from excessive heat.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

Section 50567-7

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not cover compress or wet dressing with plastic to prevent evaporation.
  • In some skin conditions, soaking too long may overdry.
Section 51727-6

Dextrin

Section 51945-4

Section 53413-1

1-855-221-5332

Distributed by:

First Nation Group, LLC

Niceville, FL 32578

Section 55105-1

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
Section 55106-9

Active Ingredients (in each packet) Purpose

Aluminum sulfate tetradecahydrate, 1347 mg Astringent*

Calcium acetate monohydrate, 952 mg Astringent*

*When combined together in water, these ingredients form the

active ingredient aluminum acetate. See Directions.


Structured Label Content

Indications and Usage (34067-9)

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
Dosage and Administration (34068-7)

Directions

  • Dissolve 1 to 3 packets in a pint (16 oz) of cool or warm water.
  • Stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.16% (1 packet), 0.32% (2 packets), or 0.48% (3packets) aluminum acetate and is ready for 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.

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.
Warnings and Precautions (34071-1)

FOR EXTERNAL USE ONLY

Section 44425-7 (44425-7)

Protect from excessive heat.

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days.

Section 50567-7 (50567-7)

When using this product

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not cover compress or wet dressing with plastic to prevent evaporation.
  • In some skin conditions, soaking too long may overdry.
Section 51727-6 (51727-6)

Dextrin

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

1-855-221-5332

Distributed by:

First Nation Group, LLC

Niceville, FL 32578

Section 55105-1 (55105-1)

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
Section 55106-9 (55106-9)

Active Ingredients (in each packet) Purpose

Aluminum sulfate tetradecahydrate, 1347 mg Astringent*

Calcium acetate monohydrate, 952 mg Astringent*

*When combined together in water, these ingredients form the

active ingredient aluminum acetate. See Directions.


Advanced Ingredient Data


Raw Label Data

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