Active Ingredient

Aluminum acetate (0.2%)

Purpose

Astringent

Uses

Scalp itch; rashes caused by soaps, detergent, or cosmetics

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. Twist the flow-control cap to open. Apply directly to scalp, rub in if needed. Consult a doctor for children under the age of two.

Store at 20-25ºC (68-77ºF). Keep carton for full product information

Questions? Visit www.dermeleve.com or call 877-684-2299

Inactive ingredients

Butylene Glycol, Calcium Chloride, Caprylyl Glycol, Disodium EDTA, Glycerin, Lactic Acid, Niacinamide, Phenoxyethanol, Polysorbate 80, Strontium Nitrate, Water, Xanthan Gum

image description

DERMELEVE ANTI ITCH SCALP SERUM
aluminum acetate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81507-004
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 mL

Ingredient Name	Strength
Inactive Ingredients
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GLYCERIN (UNII: PDC6A3C0OX)
LACTIC ACID (UNII: 33X04XA5AT)
NIACINAMIDE (UNII: 25X51I8RD4)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
STRONTIUM NITRATE (UNII: BDG873AQZL)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81507-004-01	89 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/02/2023

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M016	06/02/2023

Labeler - Advanced Derm Solutions LLC (117840544)