DR. ZENOVIA SPOT TREATMENT- benzoyl peroxide liquid

Dr. Zenovia Spot Treatment by

Drug Labeling and Warnings

Dr. Zenovia Spot Treatment 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 5.0%

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

• Blend a thin layer to affected area.
• Use once a day and increase to two or three times daily as needed.

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Bakuchiol, Camellia Sinensis (Green Tea) Polyphenols, Carbomer, Cucumis Sativus (Cucumber) Fruit Extract, Glycerin, Punica Granatum Sterols, Purified Water, Resveratrol, Sodium Hydroxymethylglycinate, Sodium Lauroyl Sarcosinate, Genistein, 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.

SPL UNCLASSIFIED SECTION

Distributed by Dr. Zenovia Skincare
Babylon, NY 11704

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

DR. ZENOVIA
HORMONAL DERMATOLOGY

CLEAR COMPLEXION

5% BENZOYL PEROXIDE
ACNE SPOT TREATMENT

bakuchiol, antioxidants

reduces acne flare-ups
and redness

15 mL / 0.5 Fl. Oz.

INGREDIENTS AND APPEARANCE

DR. ZENOVIA SPOT TREATMENT 
benzoyl peroxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51326-802
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	50 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 (UNII: YY7C30VXJT)
GLYCERIN (UNII: PDC6A3C0OX)
PUNICA GRANATUM STEROLS (UNII: UKV92KC49T)
WATER (UNII: 059QF0KO0R)
RESVERATROL (UNII: Q369O8926L)
SODIUM HYDROXYMETHYLGLYCINATE (UNII: DIG6BWZ9XT)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
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: 51326-802-01	1 in 1 BOX	06/11/2024
1		15 mL in 1 BOTTLE; 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(51326-802)