ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT)- salicylic acid stick

ZO SKIN HEALTH OFFECTS CORRECT and CONCEAL ACNE TREATMENT (LIGHT) by

Drug Labeling and Warnings

ZO SKIN HEALTH OFFECTS CORRECT and CONCEAL ACNE TREATMENT (LIGHT) by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Hudson Cosmetics MFG Corp. DBA: Paramount Cosmetics, Inc.. 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:
  5 Technology Dr.
  Irvine, CA 92618

Inactive ingredients

Euphorbia Cerifera (Candelilla) Cera, Beeswax, Polyethylene, C12-15 Alkyl Benzoate, Cyclopentasiloxane, Phenyl Trimethicone, Polybutene, Octyldodecanol, Tridecyl Stearate, Neopentyl Glycol, Dicaprylate/Dicaprate, Cellulose, Disteardimonium Hectorite, Polyglyceryl-10 Heptahydroxystearate, Silica, Helianthus Annuus (Sunflower) Seed Oil, Oleyl Alcohol, Propylene Carbonate, Water, Tridecyl Trimellitate, Triethyl Citrate, Glycerin, Zanthoxylum Bungeanum Fruit Extract, Jojoba Esters, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Ceramide NG, Trihydroxystearin, Rosmarinus Officinalis (Rosemary) Leaf Extract, Alumina, Marrubium Vulgare Meristem Cell Culture, Leontopodium Alpinum Meristem Cell Culture, Honey, Phenoxyethanol, Lecithin, Sodium Benzoate, Titanium Dioxide, Iron Oxides.

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 2.3 g Applicator Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-076-02

OFFECTS®
CORRECT & CONCEAL
ACNE TREATMENT

LIGHT

Net Wt. 2.3 g / 0.08 Oz.

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OFFECTS CORRECT AND CONCEAL ACNE TREATMENT (LIGHT) 
salicylic acid stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-076
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 g

Inactive Ingredients
Ingredient Name	Strength
CANDELILLA WAX (UNII: WL0328HX19)
YELLOW WAX (UNII: 2ZA36H0S2V)
HIGH DENSITY POLYETHYLENE (UNII: UG00KM4WR7)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
POLYBUTENE (1400 MW) (UNII: 1NA5AO9GH7)
TRIDECYL STEARATE (UNII: A8OE252M6L)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
OCTYLDODECANOL (UNII: 461N1O614Y)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ZANTHOXYLUM BUNGEANUM FRUIT (UNII: 3CIP16A418)
TEA TREE OIL (UNII: VIF565UC2G)
JOJOBA BUTTER (UNII: XIA46H803R)
CERAMIDE NG (UNII: C04977SRJ5)
ROSEMARY (UNII: IJ67X351P9)
TRIHYDROXYSTEARIN (UNII: 06YD7896S3)
ALUMINUM OXIDE (UNII: LMI26O6933)
HONEY (UNII: Y9H1V576FH)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
EGG PHOSPHOLIPIDS (UNII: 1Z74184RGV)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE RED (UNII: 1K09F3G675)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-076-02	1 in 1 CARTON	01/01/2016
1		2.3 g in 1 APPLICATOR; 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	01/01/2016

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Hudson Cosmetics MFG Corp. DBA: Paramount Cosmetics, Inc.		001321058	MANUFACTURE(42851-076)