DR. ZENOVIA ACNE CLEANSER- benzoyl peroxide liquid

Dr. Zenovia Acne Cleanser by

Drug Labeling and Warnings

Dr. Zenovia Acne Cleanser by is a Otc medication manufactured, distributed, or labeled by Topiderm, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 10.0%

Purpose

Acne Treatment

Uses

• For the treatment and management of acne
• Penetrates pores to eliminate most acne and blemishes
• Helps prevent development of new acne blemishes and blackheads

Warnings

For external use only

When using this product

• Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.
• Avoid contact with eyes. If contact occurs, flush thoroughly with water.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

• Pump a small amount of cleanser into dampened hands, and gently massage over face and neck using a circular motion.
• Rinse thoroughly with water and pat dry.

Inactive Ingredients

Aloe Barbadensis Leaf Extract, Bakuchiol, Camellia Sinensis (Green Tea) Leaf Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Disodium EDTA, Fragrance, Genistein, Glycerin, Maltodextrin, Phenoxyethanol, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Benzoate, Sodium C14-16 Olefin Sulfonate, Stearic Acid USP, Tocopheryl Acetate.

Questions?

Call (800) 445-2595 or visit drzenovia.com

REG-ulate360 Active Complex™

Resveratrol, Bakuchiol, Genistein, Camellia Sinensis (Green Tea) Polyphenols, Aloe Barbadensis Leaf Juice, Cucumis Sativus (Cucumber) Fruit Extract.

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Distributed by Dr. Zenovia Skincare
Babylon, NY 11704

PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

DR. ZENOVIA
HORMONAL DERMATOLOGY

CLEAR COMPLEXION

10% BENZOYL PEROXIDE
ACNE CLEANSER

reg-ulate360 complex™,
aloe vera, antioxidants

removes excess sebum,
impurities and buildup

120 mL / 4.0 Fl. Oz.

INGREDIENTS AND APPEARANCE

DR. ZENOVIA ACNE CLEANSER 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-803
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BAKUCHIOL (UNII: OT12HJU3AR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
CUCUMBER JUICE (UNII: 61845009SP)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)
WATER (UNII: 059QF0KO0R)
RESVERATROL (UNII: Q369O8926L)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)
GENISTEIN (UNII: DH2M523P0H)
STEARIC ACID (UNII: 4ELV7Z65AP)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51326-803-01	1 in 1 BOX	06/11/2024
1		120 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
2	NDC: 51326-803-02	1 in 1 BOX	07/25/2024
2		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH DRUG	M006	06/11/2024

Labeler - Topiderm, Inc. (049121643)

Registrant - Topiderm, Inc. (049121643)

Establishment
Name	Address	ID/FEI	Business Operations
Topiderm, Inc.		049121643	MANUFACTURE(51326-803)