24 HOUR ACNE SERUM - benzoyl peroxide gel 
Neutraderm, Inc.

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.

----------

24 Hour Acne Serum

Drug Facts

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

Use

For the treatment of acne.

Warnings

For external use only.

When using this product • avoid unnecessary sun exposure and use sunscreen. • avoid contact with eyes, lips and mouth. • avoid contact with hair and dyed products, which may be bleached by this product. • skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by physician. If irritation or sensitivity develops, stop use of product and consult physician.

Inactive Ingredients

Water, Glycolic Acid, Sclerotium Gum, Arnica Montana Flower Extract, Allantoin, Echinacea Purpurea Extract, Hydrastis Canadensis (Goldenseal) Extract, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Calendula Officinalis Flower Extract, Glycerin, Gluconolactone, Sodium Benzoate, Tetrasodium EDTA, Sodium Hydroxide

D R M T L G Y®

MEDICAL GRADE SKIN CARE

Quickly Dries Breakouts

Prevents New Breakouts

Effective for Body and Face

DRMTLGY, LLC • Chatsworth, CA

www.DRMTLGY.com • Made in USA

Packaging

image description

24 HOUR ACNE SERUM  
benzoyl peroxide gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:39765-034
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
ALLANTOIN (UNII: 344S277G0Z)  
ECHINACEA PURPUREA (UNII: QI7G114Y98)  
GOLDENSEAL (UNII: ZW3Z11D0JV)  
LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLUCONOLACTONE (UNII: WQ29KQ9POT)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Colorwhite (White to Off White) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:39765-034-0132 g in 1 BOTTLE; Type 0: Not a Combination Product02/08/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D02/08/2019
Labeler - Neutraderm, Inc. (146224444)
Establishment
NameAddressID/FEIBusiness Operations
Neutraderm, Inc.146224444manufacture(39765-034)

Revised: 6/2019
Document Id: 21c73db5-9dd9-4805-b894-11ce10ad31ae
Set id: e9f99e09-a195-481b-a178-36eba74dc330
Version: 1
Effective Time: 20190607
 
Neutraderm, Inc.