ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT- salicylic acid gel

ZO MEDICAL AKNEBRIGHT Acne Spot and Pigmentation Treatment by

Drug Labeling and Warnings

ZO MEDICAL AKNEBRIGHT Acne Spot and Pigmentation Treatment by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., PAKLAB. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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.

INGREDIENTS AND APPEARANCE

ZO MEDICAL AKNEBRIGHT ACNE SPOT AND PIGMENTATION TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-072
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
DIMETHICONE (UNII: 92RU3N3Y1O)
ARBUTIN (UNII: C5INA23HXF)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
AMINOPROPYL DIHYDROGEN PHOSPHATE (UNII: D5J0Q2CM4V)
N-ACETYLGLUCOSAMINE (UNII: V956696549)
TRISILOXANE (UNII: 9G1ZW13R0G)
SUNFLOWER OIL (UNII: 3W1JG795YI)
BARLEY MALT SYRUP (UNII: 22P8DKP670)
GLUTATHIONE (UNII: GAN16C9B8O)
SODIUM SULFITE (UNII: VTK01UQK3G)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
SOY ISOFLAVONES (UNII: 71B37NR06D)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-072-01	1 in 1 CARTON
1		15 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	11/03/2014

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
PAKLAB		790530976	MANUFACTURE(42851-072)