Zo® Skin Health Astringent Solution Powder

Zo® Skin Health Astringent Solution Powder
SPL v6
SPL
SPL Set ID cb801d7e-52ad-6c16-e053-2a95a90a7a1f
Route
TOPICAL
Published
Effective Date 2022-10-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Cation (4866 mg)
Inactive Ingredients
Whey Potassium Sorbate Hydrolyzed Soy Protein (enzymatic; 2000 Mw)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-21

Description

Active Ingredients Purpose Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent* Calcium AcetateMonohydrate, 2016 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions


Medication Information

Indications and Usage

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

Description

Active Ingredients Purpose Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent* Calcium AcetateMonohydrate, 2016 mg Astringent* *When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions

Uses

For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Section 43683-2
  • Added bolded subheadings within Directions section.
Section 51945-4

Section 55106-9
Active Ingredients Purpose
Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent*
Calcium AcetateMonohydrate, 2016 mg Astringent*

*When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions

Warnings

For external use only.

Directions

For powder dosage form:

■ dissolve 1 packet in 12 oz. of cool or warm water

■ stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.45% aluminum acetate and is ready for 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

Other Information

■ Protect this product from excessive heat and direct sun

Inactive Ingredients

Avena Sativa (Oat) Kernel Protein, Chitosan, Dextrin, Hydrolyzed Soy Protein, Potassium Sorbate, Whey Protein.

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.


Structured Label Content

Uses

For temporary relief of minor skin irritations due to rashes caused by soaps, detergents, cosmetics, or jewelry.

Indications and Usage (34067-9)

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 43683-2 (43683-2)
  • Added bolded subheadings within Directions section.
Section 51945-4 (51945-4)

Section 55106-9 (55106-9)
Active Ingredients Purpose
Aluminum Sulfate Tetradecahydrate, 2850 mg Astringent*
Calcium AcetateMonohydrate, 2016 mg Astringent*

*When combined together in water, these ingredients form the active ingredient aluminum acetate. See Directions

Warnings

For external use only.

Directions

For powder dosage form:

■ dissolve 1 packet in 12 oz. of cool or warm water

■ stir until fully dissolved; do not strain or filter. The resulting mixture contains 0.45% aluminum acetate and is ready for 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

Other Information

■ Protect this product from excessive heat and direct sun

Inactive Ingredients

Avena Sativa (Oat) Kernel Protein, Chitosan, Dextrin, Hydrolyzed Soy Protein, Potassium Sorbate, Whey Protein.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

■ if condition worsens or symptoms persist for more than 7 days

Keep Out of Reach of Children. (Keep out of reach of children.)

■ if swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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