Active Ingredient

Aluminum acetate (0.2%)

Purpose

Astringent

Uses

• Insects Bites
• Minor Burn
• Athlete's foot
• Poison lvy
• Poison oak
• Poison sumac
• Rashes cause by soaps, detergents, cosmetic or jewelry

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. Consult a doctor for children under the age of two.

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

Questions ? Visit www.dermeleve.com

Manufactured for Advanced Derm Solutions LLC
Ocala, FL 34482 | dermeleve.com
U.S. Patents: 5,716,625; 5,804,203; 6,139,850; 7,404,967

Product label

image description

DERMELEVE
aluminum acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81507-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALUMINUM ACETATE (UNII: 80EHD8I43D) (ALUMINUM CATION - UNII:3XHB1D032B)	ALUMINUM ACETATE	0.2 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
SHEA BUTTER (UNII: K49155WL9Y)
TRICAPRIN (UNII: O1PB8EU98M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CERAMIDE NG (UNII: C04977SRJ5)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
DIMETHICONE, UNSPECIFIED (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
STRONTIUM NITRATE (UNII: BDG873AQZL)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81507-002-01	30 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2021
2	NDC:81507-002-02	60 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2021
3	NDC:81507-002-03	3 g in 1 POUCH; Type 0: Not a Combination Product	06/05/2021	08/04/2022
4	NDC:81507-002-04	80 g in 1 TUBE; Type 0: Not a Combination Product	06/05/2021
5	NDC:81507-002-05	2 g in 1 POUCH; Type 0: Not a Combination Product	08/04/2022
6	NDC:81507-002-06	57 g in 1 POUCH; Type 0: Not a Combination Product	05/28/2025

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/05/2021

Labeler - Advanced Derm Solutions LLC (117840544)