SPL v7
SPL
SPL Set ID 5dd4c952-8880-4c06-9c09-20c6a3cdd0f5
Route
TOPICAL
Published
Effective Date 2025-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Aluminum Cation (0.2 g)
Inactive Ingredients
Shea Butter Tricaprin Caprylyl Glycol Ceramide Ng Cetostearyl Alcohol Cetyl Alcohol Citric Acid Monohydrate Dimethicone, Unspecified Edetate Disodium Glycerin Glyceryl Stearate/peg-100 Stearate Isopropyl Myristate Magnesium Aluminum Silicate Phenoxyethanol Ammonium Acryloyldimethyltaurate, Dimethylacrylamide, Lauryl Methacrylate And Laureth-4 Methacrylate Copolymer, Trimethylolpropane Triacrylate Crosslinked (45000 Mpa.s) Polysorbate 60 Hyaluronate Sodium Strontium Nitrate Tetrahexyldecyl Ascorbate Titanium Dioxide .alpha.-tocopherol Acetate Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-04

Description

Aluminum acetate (0.2%)

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Aluminum acetate (0.2%)

Uses

• Insects Bites

• Minor Burn

• Athlete's foot 

• Poison lvy 

• Poison oak

• Poison sumac 

• Rashes cause by soaps, detergents, cosmetic or jewelry

Section 42229-5

Questions ?  Visit  www.dermeleve.com

Warnings

For external use only.

Avoidcontact with eyes.

Do not applyto open wounds.

STOP USEand ask a physician 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 physician. Consult a physician for children under the age of two.

Product Label

Active Ingredient

Aluminum acetate (0.2%)

Inactive Ingredients 

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid

Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate

Crosspolymer-6, Polysorbate 60, Sodium Hyaluronate, Strontium Nitrate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate

Water, Xanthan Gum


Structured Label Content

Uses

• Insects Bites

• Minor Burn

• Athlete's foot 

• Poison lvy 

• Poison oak

• Poison sumac 

• Rashes cause by soaps, detergents, cosmetic or jewelry

Section 42229-5 (42229-5)

Questions ?  Visit  www.dermeleve.com

Purpose

Astringent

Warnings

For external use only.

Avoidcontact with eyes.

Do not applyto open wounds.

STOP USEand ask a physician 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 physician. Consult a physician for children under the age of two.

Product Label (Product label)

Active Ingredient

Aluminum acetate (0.2%)

Inactive Ingredients  (Inactive ingredients )

Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Caprylyl Glycol, Ceramide NG, Cetearyl Alcohol, Cetyl Alcohol, Citric Acid

Dimethicone, Disodium EDTA, Glycerin, Glyceryl Stearate, Isopropyl Myristate, Magnesium Aluminum Silicate, Phenoxyethanol, Polyacrylate

Crosspolymer-6, Polysorbate 60, Sodium Hyaluronate, Strontium Nitrate, Tetrahexyldecyl Ascorbate, Titanium Dioxide, Tocopheryl Acetate

Water, Xanthan Gum


Advanced Ingredient Data


Raw Label Data

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