Dermaleve by Advanced Derm Solutions LLC

Dermaleve by

Drug Labeling and Warnings

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

Drug Details [pdf]

DERMALEVE- aluminum acetate cream 
Advanced Derm Solutions LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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.
■ Avoid contact with eyes.
■ Do not apply to open wounds.
■ STOP USE and 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 

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

Questions ?  Visit  www.dermaleve.com

Manufactured for Advanced Derm Solutions LLC
Ocala, FL 34472 | dermaleve.com
U.S. Patents: 5,716,625; 5,804,203; 6,139,850; 7,404,967

DERMALEVE 
aluminum acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81507-001
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
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)
CERAMIDE NG (UNII: C04977SRJ5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DIMETHICONE 100 (UNII: RO266O364U)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
MAGNESIUM ALUMINUM SILICATE TYPE IA (UNII: SUS08ZOA9S)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
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: 81507-001-01	30 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021	09/30/2023
2	NDC: 81507-001-02	60 g in 1 TUBE; Type 0: Not a Combination Product	01/01/2021	09/30/2023
3	NDC: 81507-001-03	3 g in 1 POUCH; Type 0: Not a Combination Product	01/01/2021	09/30/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	01/01/2021	09/30/2023

Labeler - Advanced Derm Solutions LLC (117840544)

Revised: 2/2023

Document Id: f3cdae5b-7945-1bf1-e053-2995a90aff56

34390-5

Set id: a4148bd7-ef15-47f0-96f5-0c80d9b1b2c6

Version: 3

Effective Time: 20230203