ACNE CONTROL SERUM- benzoyl peroxide lotion

Acne Control Serum by

Drug Labeling and Warnings

Acne Control Serum by is a Otc medication manufactured, distributed, or labeled by Private Label Skin Care. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Benzoyl Peroxide 5%

Purpose

Acne Medication

INDICATIONS & USAGE

Use For the treatment of acne.

WARNINGS

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.

DOSAGE & ADMINISTRATION

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 INGREDIENT

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

SPL UNCLASSIFIED SECTION

brand MD®

SKIN CARE

ACNE DEFENSE

medical grade

√ Clinically proven to decrease sebum production by up to 70%

√ Fights acne-causing bacteria on the spot and prevents future breakouts

brandMD® Chatsworth, CA 91311

www.brandMD.com

Made in USA

Packaging

INGREDIENTS AND APPEARANCE

ACNE CONTROL SERUM 
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72957-001
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 WHOLE (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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72957-001-01	32 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/23/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333D	01/23/2020

Labeler - Private Label Skin Care (116996962)

Establishment
Name	Address	ID/FEI	Business Operations
Private Label Skin Care		116996962	relabel(72957-001)