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 

Water, Strontium Nitrate, Isopropyl Myristate, Butyrospermum Parkii (shea) Butter, Caprylyc/Capric Triglyceride, Cetearyl Alcohol, Emulsifying Wax NF, Glycerin, Phenoxyethanol, Magnesium Aluminum Silicate, Glyceryl Stearate, Dimethicone, Polyacrylate Crosspolymer-6, Xanthan Gum, Caprylyl Glycol, Sodium Hyaluronate, Disodium EDTA, Ceramide NG, Tocopherol (Vitamin E), Tetrahexyldecyl Ascorbate

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
CERAMIDE NG (UNII: C04977SRJ5)
GLYCERYL MONO- AND DICAPRYLOCAPRATE (UNII: U72Q2I8C85)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYACRYLIC ACID (450000 MW) (UNII: KD3S7H73D3)
HYALURONIC ACID (UNII: S270N0TRQY)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
DIMETHICONE 100 (UNII: RO266O364U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLAWAX POLYSORBATE (UNII: Q504PL8E0V)
SHEA BUTTER (UNII: K49155WL9Y)
STRONTIUM NITRATE (UNII: BDG873AQZL)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
WATER O-18 (UNII: 7QV8F8BYNJ)
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

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)