AQUA PLUS ACNE TREATMENT SYSTEM- salicylic acid 
Totally Clear Products, 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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Aqua Plus Acne Treatment System

daily CLEANSER

Drug Facts

Active Ingredients

Salicylic Acid 2.0%

Purpose

Acne Treatment

Uses

For The Treatment of Acne

Warnings - For External Use Only

When Using This Product:

  • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
  • 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.
  • Limit use to face and neck.

Keep Out Of Reach Of Children

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Wet your skin and massage the Aqua+ Daily Cleanser over your entire face, avoiding your eyes. Use the Aqua+ Daily Cleanser only once a day until your skin acclimates, after which you can move to twice-per-day applications. Rinse with water and gently pat your skin with a clean towel.

Water, Sodium Laureth Sulfate, Cetyl Alcohol, Glycerin, Aloe Barbadensis Leaf Extract, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Glyceryl Stearate, Green Tea (Camellia Sinensis) Leaf Extract, Sodium Ascorbic Phosphate, dl-Panthenol, Tocopheryl Acetate, Retinyl Palmitate, Xanthum Gum, Steareth-21, Squalane, Dimethicone, Polysorbate-60, Cprylyl Glycol, Steareth-2, Versene Na, Phosphoric Acid, Propylene Glycol, Hydrobromic Acid, Citric Acid, Glutaric Acid, Methylisothiazolinone

Other Information

Store in a cool, dry place. Do not freeze.

refreshing TONER

Drug Facts

Active Ingredients

Salicylic Acid 1.0%

Purpose

Acne Treatment

Uses

For The Treatment Of Acne

Warnings - For External Use Only

When Using This Product:

  • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
  • 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.
  • Limit use to face and neck.

Keep Out Of Reach Of Children

  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Water, Propylene Glycol, SD Alcohol 40B, Cocamidopropyl Dimethylamine, Isoceteh-20, Salix Alba (Willow) Bark Extract, Methyl Gluceth-20, Caprylyl Glycol, Tetrasodium EDTA, Sodium Hydroxide, Phosphoric Acid, Hydrobromic Acid, Citric Acid, Glutaric Acid, Methlisothiazolinone

Other Information

Store in a cool, dry place. Do not freeze.

spotter GEL

Drug Facts

Active Ingredients

Salicylic Acid 1.5%

Purpose

Acne Treatment

Uses

For The Treatment Of Acne

Warnings - For External Use Only

When Using This Product:

  • Avoid contact with eyes and mouth. If contact occurs, rinse thoroughly with water.
  • 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.
  • Limits use to face and neck.

Keep Out Of Reach Of Children

  • If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

Clean the skin thoroughly before applying the Aqua+ Spotter Gel. 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.

Water, Propylene Glycol, SD Alcohol 40B, Cocamidopropyl Dimethylamine, Butylene Glycol, Polyquaternium-10, Spirea ulmaria (Meadowsweet) Flower Extract, Triticum Vuldare (Wheat) Germ Extract, Tetrasodium ETDA, Caprylyl Glycol, Phosphoric Acid, Hydrobromic Acid, Citric Acid, Glutaric Acid, Methylisothiazolinone

Other Information

Store in a cool, dry place. Do not freeze.

System Labeling

System Label

Aqua Plus Daily Cleanser

Daily Cleanser Label

Aqua Plus Refreshing Toner Label

Refreshing Toner Label

Aqua Plus Spotter Gel Label

Spotter Gel

AQUA PLUS ACNE TREATMENT SYSTEM 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71471-269
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71471-269-271 in 1 BOX; Type 1: Convenience Kit of Co-Package09/01/2017
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 50 mL
Part 21 BOTTLE 30 mL
Part 31 BOTTLE 50 mL
Part 1 of 3
AQUA PLUS DAILY CLEANSER 
salicylic acid solution
Product Information
Item Code (Source)NDC:71471-561
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM LAURETH-3 SULFATE (UNII: BPV390UAP0)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
XANTHAN GUM (UNII: TTV12P4NEE)  
STEARETH-21 (UNII: 53J3F32P58)  
SQUALANE (UNII: GW89575KF9)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
STEARETH-2 (UNII: V56DFE46J5)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYDROBROMIC ACID (UNII: 3IY7CNP8XJ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLUTARIC ACID (UNII: H849F7N00B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71471-561-2750 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2017
Part 2 of 3
AQUA PLUS SPOTTER GEL 
salicylic acid gel
Product Information
Item Code (Source)NDC:71471-312
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID15 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
WHEAT GERM (UNII: YR3G369F5A)  
EDETATE SODIUM (UNII: MP1J8420LU)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
HYDROBROMIC ACID (UNII: 3IY7CNP8XJ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLUTARIC ACID (UNII: H849F7N00B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71471-312-2730 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2017
Part 3 of 3
AQUA PLUS REFRESHING TONER 
salicylic acid solution
Product Information
Item Code (Source)NDC:71471-416
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
COCAMIDOPROPYL DIMETHYLAMINE (UNII: L36BM7DG2T)  
ISOCETETH-20 (UNII: O020065R7Z)  
WILLOW BARK (UNII: S883J9JDYX)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
EDETATE SODIUM (UNII: MP1J8420LU)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PHOSPHORIC ACID (UNII: E4GA8884NN)  
HYDROBROMIC ACID (UNII: 3IY7CNP8XJ)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLUTARIC ACID (UNII: H849F7N00B)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71471-416-2750 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D09/01/2017
Labeler - Totally Clear Products, Inc (080687729)

Revised: 12/2017
Document Id: 610897df-2781-a1c7-e053-2991aa0ae350
Set id: 2774453d-170e-4dca-96e2-60bdee79d28a
Version: 3
Effective Time: 20171223
 
Totally Clear Products, Inc