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CEBATROL Oil Control Pads

Dosage form: solution
Ingredients: SALICYLIC ACID 20mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-071

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® 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 - 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)

CEBATROL OIL CONTROL PADS 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-071
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
PROPYLENE GLYCOL 
MANDELIC ACID 
UREA 
HAMAMELIS VIRGINIANA TOP 
MENTHYL LACTATE, (-)- 
DALTEPARIN SODIUM 
GLYCOLIC ACID 
TERT-BUTYL ALCOHOL 
BUTYLENE GLYCOL 
FILIPENDULA ULMARIA ROOT 
SANDALWOOD 
PLANTAGO LANCEOLATA LEAF 
PHELLODENDRON AMURENSE BARK 
BARLEY 
CRITHMUM MARITIMUM 
NORETHINDRONE 
ARTEMISIA VULGARIS ROOT 
PHENOXYETHANOL 
DENATONIUM BENZOATE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:42851-071-071 BOTTLE, GLASS in 1 CARTON
175 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2012
ZO MEDICAL CEBATROL OIL CONTROL PADS ACNE TREATMENT 
salicylic acid solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-075
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
PROPYLENE GLYCOL 
MANDELIC ACID 
UREA 
HAMAMELIS VIRGINIANA TOP 
MENTHYL LACTATE, (-)- 
DALTEPARIN SODIUM 
GLYCOLIC ACID 
TERT-BUTYL ALCOHOL 
BUTYLENE GLYCOL 
FILIPENDULA ULMARIA ROOT 
SANDALWOOD 
PLANTAGO LANCEOLATA LEAF 
PHELLODENDRON AMURENSE BARK 
BARLEY 
CRITHMUM MARITIMUM 
NORETHINDRONE 
ARTEMISIA VULGARIS ROOT 
PHENOXYETHANOL 
DENATONIUM BENZOATE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:42851-075-0020 PACKET in 1 CARTON
11 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D04/01/2015
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
Lifetech Resources622559110MANUFACTURE(42851-071, 42851-075)

Revised: 07/2015
 
ZO Skin Health, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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