Label: AQUA PLUS ACNE TREATMENT SYSTEM- salicylic acid kit

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated December 23, 2017

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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

  • INGREDIENTS AND APPEARANCE
    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)
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