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ZO SKIN HEALTH GSR (Getting Skin Ready) SYSTEM

Dosage form: kit
Ingredients: ; SALICYLIC ACID 20mg in 1mL
Labeler: ZO Skin Health, Inc.
NDC Code: 42851-172

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.

ZO® SKIN HEALTH GSR (Getting Skin Ready) SYSTEM

Drug Facts

Active ingredient

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

Control acne breakouts, oiliness and soothe complexion.

Warnings

For external use only.

Talk to your doctor if you experience excessive burning, dryness, or irritation.

Avoid the eyes, mouth, lips, and mucous membranes.

Do not use on sunburned, windburned, dry, chapped, irritated, or wounded skin.

Keep out of the reach of children.

Directions
  • Rinse and dry your face.
  • Use pads twice a day, AM and PM.

Sunburn Alert

This product contains an alpha hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn. Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

Other information

You may report a serious adverse reaction to: 5 Technology Dr., Irvine, CA 92618

Inactive ingredients

Water, Alcohol Denat., Propylene Glycol, Urea, Sodium Hydroxide, Fragrance, Glycolic Acid, Butylene Glycol, Denatonium Benzoate, t-Butyl Alcohol, Sodium Chloride, Sodium Carbonate, Spiraea Ulmaria Extract, Pterocarpus Santalinus Wood Extract, Plantago Major Leaf Extract, Phellodendron Amurense Bark Extract, Hordeum Vulgare Seed Extract, Crithmum Maritimum Extract, Camellia Sinensis Leaf Oil, Artemisia Vulgaris Extract, Phenoxyethanol.

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

PRINCIPAL DISPLAY PANEL - Kit Carton

ZO® SKIN HEALTH
BY ZEIN OBAGI MD

NDC 42851-172-07

ZO® GSR SYSTEM

For All Skin Types

Established Pharmacological Class
SubstancePharmacological Class
OFFECTS EXFOLIATING CLEANSERCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
OFFECTS EXFOLIATING POLISHCLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, AND PADS)
ZO SKIN HEALTH GSR (GETTING SKIN READY) SYSTEM 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42851-172
Packaging
#Item CodePackage Description
1NDC:42851-172-071 KIT in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 40 mL
Part 21 JAR 16.2 g
Part 31 BOTTLE, GLASS 75 mL
Part 1 of 3
OFFECTS EXFOLIATING CLEANSER 
Product Information
Ingredients
Ingredient NameQuantity
WATER 
SODIUM LAURETH-3 SULFATE 
GLYCERIN 
COCAMIDOPROPYL HYDROXYSULTAINE 
COCAMIDOPROPYL BETAINE 
PHENOXYETHANOL 
MANNITOL 
SODIUM CHLORIDE 
SODIUM HYDROXIDE 
DISODIUM COCOAMPHODIACETATE 
CAPRYLIC ALCOHOL 
POWDERED CELLULOSE 
ETHYLHEXYLGLYCERIN 
HEXYLENE GLYCOL 
EDETATE DISODIUM 
AMMONIUM LACTATE 
POLYSORBATE 20 
POLYOXYL 40 HYDROGENATED CASTOR OIL 
TEA TREE OIL 
NIACIN 
.ALPHA.-TOCOPHEROL ACETATE 
SODIUM GLYCOLATE 
SALICYLIC ACID 
NIACINAMIDE 
BIOSACCHARIDE GUM-1 
SODIUM PYRROLIDONE CARBOXYLATE 
HYPROMELLOSES 
BUTYLENE GLYCOL 
CHROMIUM HYDROXIDE GREEN 
Packaging
#Item CodePackage Description
140 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC
Part 2 of 3
OFFECTS EXFOLIATING POLISH 
Product Information
Ingredients
Ingredient NameQuantity
POLYETHYLENE GLYCOL 400 
SODIUM BICARBONATE 
DIETHYLENE GLYCOL MONOETHYL ETHER 
MAGNESIUM OXIDE 
GLYCERIN 
OLETH-20 
GLYCERYL MONOSTEARATE 
TRIHYDROXYSTEARIN 
PEG-100 STEARATE 
.ALPHA.-TOCOPHEROL ACETATE 
TETRAHEXYLDECYL ASCORBATE 
VITAMIN A PALMITATE 
TEA TREE OIL 
ASCORBYL PALMITATE 
STEARYL GLYCYRRHETINATE 
PROPYLPARABEN 
LECITHIN, SOYBEAN 
LINOLEIC ACID 
SOY STEROL 
MEDIUM-CHAIN TRIGLYCERIDES 
D&C GREEN NO. 6 
Packaging
#Item CodePackage Description
116.2 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC
Part 3 of 3
OFFECTS TE-PADS ACNE PORE TREATMENT SYSTEM 
salicylic acid solution
Product Information
Item Code (Source)NDC:42851-078
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALCOHOL 
PROPYLENE GLYCOL 
UREA 
DALTEPARIN SODIUM 
GLYCOLIC ACID 
TERT-BUTYL ALCOHOL 
BUTYLENE GLYCOL 
FILIPENDULA ULMARIA ROOT 
SANDALWOOD 
PLANTAGO LANCEOLATA LEAF 
PHELLODENDRON AMURENSE BARK 
BARLEY 
CRITHMUM MARITIMUM 
GREEN TEA LEAF 
ARTEMISIA VULGARIS ROOT 
PHENOXYETHANOL 
DENATONIUM BENZOATE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage Description
1NDC:42851-078-0775 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D01/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2011
Labeler - ZO Skin Health, Inc. (826468527)
Establishment
NameAddressID/FEIOperations
Lifetech Resources622559110MANUFACTURE(42851-172)

Document Id: 72cb67ed-36ab-49a7-9a24-4a7180b924a8
Set id: a82129fc-0b0d-4ade-96cd-94917caac930
Version: 1
Effective Time: 20160112
 
ZO Skin Health, Inc.

Medically reviewed on Jan 14, 2019

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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