DERMELEVE- aluminum acetate cream

Dermeleve by

Drug Labeling and Warnings

Dermeleve by is a Otc medication manufactured, distributed, or labeled by Advanced Derm Solutions LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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

SPL UNCLASSIFIED SECTION

Questions ?  Visit  www.dermeleve.com

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

DERMELEVE 
aluminum acetate cream

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

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

Inactive Ingredients
Ingredient Name	Strength
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	06/05/2021

Labeler - Advanced Derm Solutions LLC (117840544)