ZO
® Skin Health Skin Normalizing System Therapeutic Treatment for red, sensitized skin
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
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.
SKIN NORMALIZING SYSTEM Therapeutic treatment for red, sensitized skin
NDC 42851-111-60
GENTLE CLEANSER 60 mL / 2 Fl. Oz.
EXFOLIATING POLISH Net Wt. 16.2 g / 0.57 Oz.
OIL CONTROL PADS 60 Pads
DAILY POWER DEFENSE 30 mL / 1 Fl. Oz.
ROZATROL® 20 mL / 0.67 Fl. Oz.
Established Pharmacological Class
Substance
Pharmacological Class
ZO Skin Health Gentle Cleanser
Cleansing (cold creams, cleansing lotions, liquids, and pads)
ZO Skin Health Exfoliating Polish
Lotions, Oils, Powders, and Creams
ZO Skin Health Daily Power Defense
Lotions, Oils, Powders, and Creams
ZO Skin Health Rozatrol Treatment for red, sensitized skin
Lotions, Oils, Powders, and Creams
ZO SKIN HEALTH SKIN NORMALIZING SYSTEM THERAPEUTIC TREATMENT FOR RED, SENSITIZED SKIN
salicylic acid kit
Product Information
Product Type
HUMAN OTC DRUG
Item Code (Source)
NDC:42851-111
Packaging
#
Item Code
Package Description
1
NDC:42851-111-60
1 KIT in 1 CARTON
Quantity of Parts
Part #
Package Quantity
Total Product Quantity
Part 1
1 TUBE
60 mL
Part 2
1 JAR
16.2 g
Part 3
60 PATCH
48 mL
Part 4
1 BOTTLE
30 mL
Part 5
1 TUBE
20 mL
Part 1 of 5
ZO SKIN HEALTH GENTLE CLEANSER
lotion
Product Information
Route of Administration
TOPICAL
DEA Schedule
Ingredients
Ingredient Name
Quantity
WATER
SODIUM LAURETH-3 SULFATE
COCAMIDOPROPYL BETAINE
SODIUM LAUROYL OAT AMINO ACIDS
GLYCERIN
PTEROCARPUS SOYAUXII WOOD
PHELLODENDRON AMURENSE BARK
BARLEY
GREEN TEA LEAF
PLANTAGO LANCEOLATA LEAF
CRITHMUM MARITIMUM
LIMONENE, (+)-
LINALOOL, (+/-)-
SODIUM CHLORIDE
BUTYLENE GLYCOL
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
FD&C BLUE NO. 1
D&C RED NO. 33
Packaging
#
Item Code
Package Description
1
60 mL in 1 TUBE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
Cosmetic
05/01/2018
Part 2 of 5
ZO SKIN HEALTH EXFOLIATING POLISH
cream
Product Information
Route of Administration
TOPICAL
DEA Schedule
Ingredients
Ingredient Name
Quantity
POLYETHYLENE GLYCOL 400
SODIUM BICARBONATE
MAGNESIUM OXIDE
DIETHYLENE GLYCOL MONOETHYL ETHER
GLYCERIN
BUTYLENE GLYCOL
OLETH-20
TRIHYDROXYSTEARIN
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
MINERAL OIL
WATER
.ALPHA.-TOCOPHEROL ACETATE
TEA TREE OIL
SOY STEROL
LIMONENE, (+)-
LINALOOL, (+/-)-
ASCORBYL PALMITATE
VITAMIN A PALMITATE
STEARYL GLYCYRRHETINATE
TETRAHEXYLDECYL ASCORBATE
MEDIUM-CHAIN TRIGLYCERIDES
LINOLEIC ACID
LECITHIN, SOYBEAN
PHENOXYETHANOL
D&C GREEN NO. 6
Packaging
#
Item Code
Package Description
1
16.2 g in 1 JAR
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
Cosmetic
05/01/2018
Part 3 of 5
ZO SKIN HEALTH OIL CONTROL PADS, ACNE TREATMENT
salicylic acid patch
Product Information
Route of Administration
TOPICAL
DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name
Basis of Strength
Strength
SALICYLIC ACID (SALICYLIC ACID)
SALICYLIC ACID
20 mg in 1 mL
Inactive Ingredients
Ingredient Name
Strength
ALCOHOL
BUTYLENE GLYCOL
GREEN TEA LEAF
CRITHMUM MARITIMUM
GLYCOLIC ACID
HAMAMELIS VIRGINIANA TOP
BARLEY
MANDELIC ACID
MENTHYL LACTATE, (-)-
PHENOXYETHANOL
PLANTAGO LANCEOLATA LEAF
PTEROCARPUS SOYAUXII WOOD
ROSA CANINA FRUIT
SODIUM HYDROXIDE
UREA
WATER
Packaging
#
Item Code
Package Description
1
60 PATCH in 1 JAR
1
0.8 mL in 1 PATCH
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
part333D
05/01/2018
Part 4 of 5
ZO SKIN HEALTH DAILY POWER DEFENSE
lotion
Product Information
Route of Administration
TOPICAL
DEA Schedule
Ingredients
Ingredient Name
Quantity
WATER
CETEARYL ISONONANOATE
CYCLOMETHICONE 5
GLYCERIN
CYCLOMETHICONE 6
PENTYLENE GLYCOL
CETOSTEARYL ALCOHOL
STEARETH-20
C14-22 ALCOHOLS
CETEARYL GLUCOSIDE
C12-20 ALKYL GLUCOSIDE
CARBOXYPOLYMETHYLENE
LACTOSE, UNSPECIFIED FORM
POWDERED CELLULOSE
LECITHIN, SOYBEAN
RETINOL
1,2-HEXANEDIOL
HYPROMELLOSE, UNSPECIFIED
ARABIDOPSIS THALIANA
ORANGE OIL
MANDARIN OIL
LEMON OIL
PEPPERMINT OIL
MIMOSA TENUIFLORA BARK
TANGERINE
POLYSORBATE 20
FARNESOL
LIMONENE, (+)-
EDETATE DISODIUM ANHYDROUS
SODIUM HYDROXIDE
PALMITOYL TRIPEPTIDE-1
PALMITOYL TETRAPEPTIDE-7
VITAMIN A PALMITATE
.ALPHA.-TOCOPHEROL ACETATE
CAPRYLYL GLYCOL
BUTYLENE GLYCOL
HEXYLENE GLYCOL
ETHYLHEXYLGLYCERIN
PHENOXYETHANOL
ULTRAMARINE BLUE
EXT. D&C VIOLET NO. 2
Packaging
#
Item Code
Package Description
1
30 mL in 1 BOTTLE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
Cosmetic
05/01/2018
Part 5 of 5
ZO SKIN HEALTH ROZATROL TREATMENT FOR RED, SENSITIZED SKIN
lotion
Product Information
Route of Administration
TOPICAL
DEA Schedule
Ingredients
Ingredient Name
Quantity
WATER
GLYCERIN
CETYL ALCOHOL
SUNFLOWER OIL
ALKYL (C12-15) BENZOATE
PALMITOYL GLYCINE
NEOPENTYL GLYCOL DIETHYLHEXANOATE
DIMETHICONE
PANTHENOL
GLYCERYL MONOSTEARATE
PEG-100 STEARATE
POTASSIUM CETYL PHOSPHATE
LACTOSE, UNSPECIFIED FORM
CASEIN
NEOPENTYL GLYCOL DIISOSTEARATE
PAPAIN
MAGNESIUM ALUMINUM SILICATE
PEG-12 GLYCERYL LAURATE
POLYOXYL 35 CASTOR OIL
PANTHENOL TRIACETATE, (+)-
FARNESOL
FARNESYL ACETATE
AMINOMETHYLPROPANOL
CAPRYLYL GLYCOL
EDETATE DISODIUM ANHYDROUS
CARBOXYPOLYMETHYLENE
LECITHIN, SOYBEAN
SODIUM ALGINATE
XANTHAN GUM
BENZALKONIUM CHLORIDE
CHLORPHENESIN
PHENOXYETHANOL
Packaging
#
Item Code
Package Description
1
20 mL in 1 TUBE
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
Cosmetic
05/01/2018
Marketing Information
Marketing Category
Application Number or Monograph Citation
Marketing Start Date
Marketing End Date
OTC monograph final
part333D
05/01/2018
Labeler - ZO Skin Health, Inc.
(826468527)
Establishment
Name
Address
ID/FEI
Operations
Lifetech Resources, LLC
081239587
manufacture(42851-111)
Establishment
Name
Address
ID/FEI
Operations
Thibiant International, Inc.
083913913
manufacture(42851-111)
Establishment
Name
Address
ID/FEI
Operations
PakLab
790530976
manufacture(42851-111)
Document Id: a83c1848-16fc-52e0-e053-2995a90ae031
Set id: 3009fce8-9134-4cda-be25-4a1f8480f9ef
Version: 2
Effective Time: 20200616
ZO Skin Health, Inc.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
