ZO SKIN HEALTH OIL CONTROL PADS ACNE TREATMENT- salicylic acid patch

ZO Skin Health Oil Control Pads Acne Treatment by

Drug Labeling and Warnings

ZO Skin Health Oil Control Pads Acne Treatment by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active ingredient

Salicylic acid 2.0%

Purpose

Acne treatment

Uses

• for the management of acne.
• penetrates pores to control acne blemishes.

Warnings

Flammable. Keep away from heat and open flame.

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.

Stop use and ask a doctor if

• skin irritation occurs or gets worse.

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

• Read the directions and warnings before use.
• Store at 15–30°C (59–89°F), away from direct sunlight.

Inactive ingredients

Alcohol, Artemisia Vulgaris Extract, Butylene Glycol, Camellia Sinensis Leaf Extract, Crithmum Maritimum Extract, Fragrance, Glycolic Acid, Hamamelis Virginiana (Witch Hazel) Extract, Hordeum Vulgare Seed Extract, Mandelic Acid, Menthyl Lactate, Phenoxyethanol, Phellodendron Amureuse Extract, Plantago Lanceolata Leaf Extract, Pterocarpus Soyauxii Wood Extract, Rosa Canina Fruit Extract, Sodium Hydroxide, Spiraea Ulmaria Extract, Urea, Water.

Questions?

5 Technology Dr. Irvine, CA 92618

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Dist. by ZO Skin Health, Inc. Irvine, CA 92618

PRINCIPAL DISPLAY PANEL - 60 Pad Jar Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC: 42851-085-60

OIL CONTROL PADS
ACNE TREATMENT

2% Salicylic Acid

60 Pads

INGREDIENTS AND APPEARANCE

ZO SKIN HEALTH OIL CONTROL PADS ACNE TREATMENT 
salicylic acid patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42851-085
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
Alcohol (UNII: 3K9958V90M)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
Butylene Glycol (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
Glycolic Acid (UNII: 0WT12SX38S)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
BARLEY (UNII: 5PWM7YLI7R)
Mandelic Acid (UNII: NH496X0UJX)
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)
Phenoxyethanol (UNII: HIE492ZZ3T)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PTEROCARPUS SOYAUXII WOOD (UNII: 0V6QB4C61P)
ROSA CANINA FRUIT (UNII: 3TNW8D08V3)
Sodium Hydroxide (UNII: 55X04QC32I)
Urea (UNII: 8W8T17847W)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-085-60	1 in 1 CARTON	11/01/2017
1		60 in 1 JAR
1		0.8 mL in 1 PATCH; Type 0: Not a Combination Product
2	NDC: 42851-085-30	1 in 1 CARTON	07/11/2018
2		30 in 1 JAR
2		0.8 mL in 1 PATCH; 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	11/01/2017

Labeler - ZO Skin Health, Inc. (826468527)

Establishment
Name	Address	ID/FEI	Business Operations
Lifetech Resources, LLC		622559110	MANUFACTURE(42851-085)