24 HOUR ACNE SERUM- benzoyl peroxide gel

24 Hour Acne Serum by

Drug Labeling and Warnings

24 Hour Acne Serum by is a Otc medication manufactured, distributed, or labeled by Neutraderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

24 HOUR ACNE SERUM  
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 39765-034
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	5 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (White to Off White)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 39765-034-01	32 g in 1 BOTTLE; Type 0: Not a Combination Product	02/08/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	02/08/2019

Labeler - Neutraderm, Inc. (146224444)

Establishment
Name	Address	ID/FEI	Business Operations
Neutraderm, Inc.		146224444	manufacture(39765-034)