5dd4c952-8880-4c06-9c09-20c6a3cdd0f5

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

Purpose

Astringent

Description

Aluminum acetate (0.2%)


Medication Information

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.

Uses

• Insects Bites

• Minor Burn

• Athlete's foot 

• Poison lvy 

• Poison oak

• Poison sumac 

• Rashes cause by soaps, detergents, cosmetic or jewelry

Purpose

Astringent

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.

Description

Aluminum acetate (0.2%)

Section 42229-5

Questions ?  Visit  www.dermeleve.com

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

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.

Uses

• Insects Bites

• Minor Burn

• Athlete's foot 

• Poison lvy 

• Poison oak

• Poison sumac 

• Rashes cause by soaps, detergents, cosmetic or jewelry

Purpose

Astringent

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.

Section 42229-5 (42229-5)

Questions ?  Visit  www.dermeleve.com

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

All Sections (JSON)