bc58b347-a3cb-4b36-8041-62d948438a81

SPL v11
SPL
SPL Set ID bc58b347-a3cb-4b36-8041-62d948438a81
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 2021-06-05 Until 2022-08-04

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 doctor 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 doctor. Consult a doctor 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 doctor 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 doctor. Consult a doctor 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

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