OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM- salicylic acid solution

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM by

Drug Labeling and Warnings

OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM by is a Otc medication manufactured, distributed, or labeled by ZO Skin Health, Inc., Lifetech Resources. 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 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.

SPL UNCLASSIFIED SECTION

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 - 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)

INGREDIENTS AND APPEARANCE

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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-078-07	75 mL in 1 BOTTLE, GLASS; 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	01/01/2011

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

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)
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42851-079-00	20 in 1 CARTON
1		1 mL in 1 PACKET; 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	04/05/2015

Labeler - ZO Skin Health, Inc. (826468527)

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