CEBATROL OIL CONTROL PADS- salicylic acid solution
ZO MEDICAL CEBATROL OIL CONTROL PADS ACNE TREATMENT- salicylic acid solution
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.

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ZO® MEDICAL CEBATROL™ Oil Control Pads Acne Treatment

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

for the management of acne.

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.

Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

clean the skin thoroughly before applying this product
cover the entire affected area with a thin layer one to two times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Other information

Store at controlled room temperature: 15–30°C (59–89°F), away from direct sunlight
You may report a serious adverse reaction to:
5 Technology Dr. Irvine, CA 92618

Inactive ingredients

Water, SD Alcohol 40-B, Propylene Glycol, Mandelic Acid, Urea, Hamamelis Virginiana (Witch Hazel) Extract, Menthyl Lactate, Alcohol, Fragrance, Glycolic Acid, t-Butyl Alcohol, Butylene Glycol, Spiraea Ulmaria Extract, Santalum Album (Sandalwood) Extract, Plantago Lanceolata Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Distichon (Barley) Extract, Crithmum Maritimum Extract, Camellia, Sinensis Leaf Extract, Artemisia Vulgaris Extract, Phenoxyethanol, Denatonium Benzoate, Sodium Hydroxide.

DIST BY
ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-071-07

CEBATROL™
Oil Control Pads
Acne Treatment

60 Pads, 75 mL / 2.5 Fl. Oz.

Principal Display Panel - 75 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 20 Packet Carton

ZO®MEDICAL
BY ZEIN OBAGI, MD

NDC 42851-075-00

CEBATROL™
Oil Control Pads
Acne Treatment

20 Single-Use Packettes (1mL / 0.03 Fl. Oz. each)

PRINCIPAL DISPLAY PANEL - 20 Packet Carton

CEBATROL OIL CONTROL PADS
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-071
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MANDELIC ACID (UNII: NH496X0UJX)
UREA (UNII: 8W8T17847W)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
SANDALWOOD (UNII: 3641YW25N2)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
NORETHINDRONE (UNII: T18F433X4S)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-071-07	1 in 1 CARTON	01/01/2012	10/01/2018
1		75 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	01/01/2012	10/01/2018

ZO MEDICAL CEBATROL OIL CONTROL PADS ACNE TREATMENT
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-075
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MANDELIC ACID (UNII: NH496X0UJX)
UREA (UNII: 8W8T17847W)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
SANDALWOOD (UNII: 3641YW25N2)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
NORETHINDRONE (UNII: T18F433X4S)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-075-00	20 in 1 CARTON	04/01/2015	10/01/2018
1		1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/01/2015	10/01/2018

Labeler - ZO Skin Health, Inc. (826468527)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources		622559110	manufacture(42851-071, 42851-075)

Revised: 3/2023

Document Id: f7ff5420-03b2-03bd-e053-6394a90a599e

Set id: 5a8ba70b-1f5b-4838-8463-a3143e635d8e

Version: 4

Effective Time: 20230328

ZO Skin Health, Inc.