ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE- benzoyl peroxide cream

ZO Skin Health Acne Control Benzoyl Peroxide by

Drug Labeling and Warnings

ZO Skin Health Acne Control Benzoyl Peroxide by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpose

Acne Medication

Uses

For the treatment of acne.

Warnings

For external use only.

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide.

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 unnecessary sun exposure and use a sunscreen
• avoid contact with the eyes, lips, and mouth
• avoid contact with hair and dyed fabrics, 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.

Stop use and ask a doctor if

• irritation becomes severe

Keep out of reach of children.

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

Directions

Sensitivity Test for a New User.

Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated below.

• Clean the skin thoroughly before applying this product.
• Cover the entire affected area with a thin layer one to three times daily.
• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
• If going outside, apply sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

Aqua/Water/Eau, Aspalathus Linearis Leaf Extract, Camellia Sinensis Leaf Extract, Carbomer, Diethylhexyl Sodium Sulfosuccinate, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin, Melaleuca Alternifolia (Tea Tree) Leaf Oil, PEG-40 Stearate, PEG-8 Laurate, Phenoxyethanol, Pinus Strobus Bark Extract, Polyglyceryl-6 Isostearate, Propanediol, Propylene Glycol, Silica, Sodium Citrate, Sodium Hydroxide, Sorbitan Stearate, Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

SPL UNCLASSIFIED SECTION

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 60 mL Tube Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-087-60

ACNE CONTROL
10% Benzoyl Peroxide

60 mL / 2 Fl. Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE 
benzoyl peroxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-087
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
Water (UNII: 059QF0KO0R)
Aspalathus Linearis Leaf (UNII: H7UGK1GJCU)
Green Tea leaf (UNII: W2ZU1RY8B0)
Carbomer Homopolymer, unspecified type (UNII: 0A5MM307FC)
Docusate Sodium (UNII: F05Q2T2JA0)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium anhydrous (UNII: 8NLQ36F6MM)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Tea tree oil (UNII: VIF565UC2G)
PEG-40 Stearate (UNII: ECU18C66Q7)
PEG-8 Laurate (UNII: 762O8IWA10)
Phenoxyethanol (UNII: HIE492ZZ3T)
Pinus Strobus Bark (UNII: 8PJ4761097)
Polyglyceryl-6 Isostearate (UNII: 5VKGO1O03G)
Propanediol (UNII: 5965N8W85T)
Propylene Glycol (UNII: 6DC9Q167V3)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Citrate, unspecified form (UNII: 1Q73Q2JULR)
Sodium Hydroxide (UNII: 55X04QC32I)
Sorbitan Monostearate (UNII: NVZ4I0H58X)
Vitis Vinifera seed (UNII: C34U15ICXA)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-087-60	1 in 1 CARTON	02/01/2019
1		60 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 FINAL	part333D	02/01/2019

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(42851-087)