CEBATROL Oil Control Pads description, usages, side effects, indications, overdosage, supplying and lots more!

CEBATROL Oil Control Pads

ZO Skin Health, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
CEBATROL™ Oil Control Pads

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

  • For the management of acne.
  • Reduces the severity of oiliness and smooths complexion.

Warnings

For external use only.

When using this product: Do not leave pad on skin.

Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.

Do not use on damaged or broken skin.

Stop and ask a doctor if you experience excessive burning, dryness, or irritation.

Avoid the eyes, mouth, lips, and mucous membranes. If contact occurs, flush thoroughly with water.

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

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards

Directions

  • Rinse and dry your face.
  • Use pads twice a day, AM and PM.

Other information

  • Protect the product in this container from excessive heat and direct sunlight.
  • You may report a serious adverse reaction to:
    1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

Water (Aqua), Alcohol, Propylene Glycol, Sodium Hydroxide, Mandelic Acid, Urea, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Denatonium Benzoate, Glycolic Acid, Hamamelis Virginiana Bark/Leaf/Twig Extract, Hordeum Distichon Extract, Menthyl Lactate, Fragrance, Phellodendron Amurense Bark Extract, Plantago Lanceolata Leaf Extract, Santalum Album Extract, Spiraea Ulmaria Extract, T-Butyl Alcohol, Triclosan.

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

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

ZO ® MEDICAL
BY ZEIN OBAGI, MD

03 n

CEBATROL
Oil Control Pads

60 Pads, 75 mL / 2.5 Fl. Oz.

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

CEBATROL Oil Control Pads

Salicylic Acid SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:42851-071
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Salicylic Acid SALICYLIC ACID 20 mg

Inactive Ingredients

Ingredient Name Strength
water
ALCOHOL
propylene glycol
SODIUM HYDROXIDE
mandelic acid
UREA
ARTEMISIA VULGARIS ROOT
BUTYLENE GLYCOL
GREEN TEA LEAF
CRITHMUM MARITIMUM
denatonium benzoate
GLYCOLIC ACID
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK
hordeum vulgare root
Menthyl Lactate, (-)-
PHELLODENDRON AMURENSE BARK
PLANTAGO LANCEOLATA LEAF
SANTALUM ALBUM SEED
FILIPENDULA ULMARIA ROOT
TERT-BUTYL ALCOHOL
TRICLOSAN

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 75 in 1 BOTTLE, GLASS
2 NDC:42851-071-07 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
partD part333D 2012-01-01


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