SPL v6
SPL
SPL Set ID c53e075e-b9cb-4434-a38d-2cf3dae0b438
Route
TOPICAL
Published
Effective Date 2025-10-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Cation (0.2 g)
Inactive Ingredients
Butylene Glycol Calcium Chloride Caprylyl Glycol Edetate Disodium Anhydrous Glycerin Lactic Acid Niacinamide Phenoxyethanol Polysorbate 80 Strontium Nitrate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-02

Description

Aluminum acetate (0.2%)

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Aluminum acetate (0.2%)

Uses

Scalp itch; rashes caused by soaps, detergent, or cosmetics

Section 42229-5

Store at 20-25ºC (68-77ºF). Keep carton for full product information

Section 50565-1

Warnings

For external use only. Avoidcontact with eyes. Do not applyto open wounds. STOP USEand ask a doctor if condition worsens or symptoms persist for more than seven days. Keep out of reach of children.

Directions

Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor. Twist the flow-control cap to open. Apply directly to scalp, rub in if needed. Consult a doctor for children under the age of two.

Product Label

Active Ingredient

Aluminum acetate (0.2%)

Inactive Ingredients

Butylene Glycol, Calcium Chloride, Caprylyl Glycol, Disodium EDTA, Glycerin, Lactic Acid, Niacinamide, Phenoxyethanol, Polysorbate 80, Strontium Nitrate, Water, Xanthan Gum


Structured Label Content

Uses

Scalp itch; rashes caused by soaps, detergent, or cosmetics

Section 42229-5 (42229-5)

Store at 20-25ºC (68-77ºF). Keep carton for full product information

Section 50565-1 (50565-1)

Purpose

Astringent

Warnings

For external use only. Avoidcontact with eyes. Do not applyto open wounds. STOP USEand ask a doctor if condition worsens or symptoms persist for more than seven days. Keep out of reach of children.

Directions

Adults and children two years of age and older, apply to affected area as needed or as directed by a doctor. Twist the flow-control cap to open. Apply directly to scalp, rub in if needed. Consult a doctor for children under the age of two.

Product Label (Product label)

Active Ingredient

Aluminum acetate (0.2%)

Inactive Ingredients (Inactive ingredients)

Butylene Glycol, Calcium Chloride, Caprylyl Glycol, Disodium EDTA, Glycerin, Lactic Acid, Niacinamide, Phenoxyethanol, Polysorbate 80, Strontium Nitrate, Water, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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