ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE- benzoyl peroxide cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Benzoyl Peroxide (UNII: W9WZN9A0GM) (Benzoyl Peroxide - UNII:W9WZN9A0GM)
Available from:
ZO Skin Health, Inc.
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Acne Medication For the treatment of acne.
Authorization status:
OTC monograph final
Authorization number:
42851-087-60

ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE- benzoyl peroxide cream

ZO Skin Health, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

ZO Skin Health Acne Control 10% Benzoyl Peroxide

Drug Facts

Active Ingredient

Benzoyl Peroxide 10%

Purpos e

Acne Medication

Us es

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.

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.

ZO SKIN HEALTH ACNE CONTROL BENZOYL PEROXIDE

benzoyl peroxide cream

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:428 51-0 8 7

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Benzo yl Pero xide (UNII: W9 WZN9 A0 GM) (Benzo yl Pero xide - UNII:W9 WZN9 A0 GM)

Benzo yl Pero xide

10 0 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

Wa ter (UNII: 0 59 QF0 KO0 R)

Aspa la thus Linea ris Lea f (UNII: H7UGK1GJCU)

Green Tea lea f (UNII: W2ZU1RY8 B0 )

Ca rbo mer Ho mo po lymer, unspecified type (UNII: 0 A5MM30 7FC)

Do cusa te So dium (UNII: F0 5Q2T2JA0 )

Dimethico ne (UNII: 9 2RU3N3Y1O)

Edeta te Diso dium a nhydro us (UNII: 8 NLQ36 F6 MM)

Ethylhexylg lycerin (UNII: 147D247K3P)

Glycerin (UNII: PDC6 A3C0 OX)

Tea tree o il (UNII: VIF56 5UC2G)

PEG-4 0 Stea ra te (UNII: ECU18 C6 6 Q7)

PEG-8 La ura te (UNII: 76 2O8 IWA10 )

Pheno xyetha no l (UNII: HIE49 2ZZ3T)

Pinus Stro bus Ba rk (UNII: 8 PJ476 10 9 7)

Po lyg lyceryl-6 Iso stea ra te (UNII: 5VKGO1O0 3G)

Pro pa nedio l (UNII: 59 6 5N8 W8 5T)

Pro pylene Glyco l (UNII: 6 DC9 Q16 7V3)

Silico n Dio xide (UNII: ETJ7Z6 XBU4)

So dium Citra te, unspecified fo rm (UNII: 1Q73Q2JULR)

So dium Hydro xide (UNII: 55X0 4QC32I)

So rbita n Mo no stea ra te (UNII: NVZ4I0 H58 X)

Vitis Vinifera seed (UNII: C34U15ICXA)

Xa ntha n Gum (UNII: TTV12P4NEE)

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

ZO Skin Health, Inc.

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:428 51-0 8 7-6 0

1 in 1 CARTON

0 2/0 1/20 19

1

6 0 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC MONOGRAPH FINAL

pa rt333D

0 2/0 1/20 19

Labeler -

ZO Skin Health, Inc. (826468527)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Phyto genX, Inc.

6 2438 6 772

MANUFACTURE(428 51-0 8 7)

Revised: 8/2019

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