OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM- salicylic acid solution
ZO Skin Health, Inc.

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.

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ZO® SKIN HEALTH OFFECTS® TE-PADS ACNE PORE TREATMENT SYSTEM

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 two times daily
because excessive drying of the skin may occur, start with one application daily, then gradually increase to two 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

Water, SD Alcohol 40-B, Propylene Glycol, Urea, Fragrance, Glycolic Acid, t-Butyl Alcohol, Butylene Glycol, Spiraea Ulmaria Extract, Santalum Album (Sandalwood) Extract, Plantago Lanceolata Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Distichon (Barley) Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Extract, Artemisia Vulgaris Extract, Phenoxyethanol, Denatonium Benzoate, Sodium Hydroxide.

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

PRINCIPAL DISPLAY PANEL - 75 mL Bottle Carton

ZO ®SKIN HEALTH
BY ZEIN OBAGI,MD

OFFECTS®
TE-PADS
ACNE PORE TREATMENT
SYSTEM

NDC 42851-078-07

60 Pads, 75 mL / 2.5 Fl. Oz.

Principal Display Panel - 75 mL Bottle Carton

PRINCIPAL DISPLAY PANEL - 20 Packet Carton

ZO ®SKIN HEALTH
BY ZEIN OBAGI,MD

NDC 42851-079-00

OFFECTS®
TE-PADS
ACNE PORE TREATMENT

20 Single-Use Packettes (1mL / 0.03 Fl. Oz. each)

Principal Display Panel - 20 Packet Carton

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-078
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UREA (UNII: 8W8T17847W)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
SANDALWOOD (UNII: 3641YW25N2)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-078-07	75 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product	01/01/2011	09/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	01/01/2011	09/01/2020

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM
salicylic acid solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42851-079
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
UREA (UNII: 8W8T17847W)
DALTEPARIN SODIUM (UNII: 12M44VTJ7B)
GLYCOLIC ACID (UNII: 0WT12SX38S)
TERT-BUTYL ALCOHOL (UNII: MD83SFE959)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
FILIPENDULA ULMARIA ROOT (UNII: 997724QNDS)
SANDALWOOD (UNII: 3641YW25N2)
PLANTAGO LANCEOLATA LEAF (UNII: 2YWL9J7EE8)
PHELLODENDRON AMURENSE BARK (UNII: PBG27B754G)
BARLEY (UNII: 5PWM7YLI7R)
CRITHMUM MARITIMUM (UNII: J7IHY79BKY)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ARTEMISIA VULGARIS ROOT (UNII: 32MP823R8S)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42851-079-00	20 in 1 CARTON	04/05/2015	12/01/2020
1		1 mL in 1 PACKET; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333D	04/05/2015	12/31/2020

Labeler - ZO Skin Health, Inc. (826468527)

Name	Address	ID/FEI	Business Operations
Establishment
Lifetech Resources		622559110	manufacture(42851-078, 42851-079)

Revised: 7/2023

Document Id: 00d9f26f-834f-99af-e063-6394a90a2037

Set id: a7a21460-dbe5-4861-a727-442419e66883

Version: 5

Effective Time: 20230719

ZO Skin Health, Inc.