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ZO MEDICAL AKNEBRIGHT Acne Spot and Pigmentation Treatment

Dosage form: gel
Ingredients: SALICYLIC ACID 20mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-072

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 AKNEBRIGHT™ Acne Spot and Pigmentation Treatment

Drug Facts

Active ingredient

Salicylic Acid, 2.0%

Purpose

Acne Treatment

Uses
  • for the treatment 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 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 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

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: 1 Technology Dr. B123, Irvine, CA 92618

Inactive ingredients

Water (Aqua), SD Alcohol 40-B (Alcohol Denat.), PEG-8, Dimethicone, Arbutin, PVM/MA Decadiene Crosspolymer, Aminopropyl Kojyl Phosphate, Pentylene Glycol, Glycerin, Sodium Hydroxide, Aminopropyl Dihydrogen Phosphate, Acetyl Glucosamine, Dimethicone/PEG-10/15 Crosspolymer, Trisiloxane, Helianthus Annuus Seed Oil, Prunus Amygdalus Dulcis Oleosomes, Mel Extract, Trimethylsiloxysilicate/Dimethiconol Crosspolymer, Alcohol, Brassica Oleracea Italica Extract, Glutathione, Sodium Sulfite, Polysorbate 80, Lecithin, Soy Isoflavones.

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

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

ZO®MEDICAL

BY ZEIN OBAGI, MD

NDC 42851-072-01

AKNEBRIGHT™
Acne Spot and
Pigmentation Treatment

15 mL / 0.5 Fl. Oz.

ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-072
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 
POLYETHYLENE GLYCOL 400 
DIMETHICONE 
ARBUTIN 
PENTYLENE GLYCOL 
GLYCERIN 
SODIUM HYDROXIDE 
AMINOPROPYL DIHYDROGEN PHOSPHATE 
N-ACETYLGLUCOSAMINE 
TRISILOXANE 
SUNFLOWER OIL 
BARLEY MALT SYRUP 
GLUTATHIONE 
SODIUM SULFITE 
POLYSORBATE 80 
EGG PHOSPHOLIPIDS 
SOY ISOFLAVONES 
Packaging
#Item CodePackage Description
1NDC:42851-072-011 TUBE in 1 CARTON
115 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D11/03/2014
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
PAKLAB790530976MANUFACTURE(42851-072)

 
ZO Skin Health, Inc.

Medically reviewed on Feb 12, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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