Label: AQUA PLUS ACNE TREATMENT SYSTEM- salicylic acid kit
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Contains inactivated NDC Code(s)
NDC Code(s): 71471-269-27, 71471-312-27, 71471-416-27, 71471-561-27 - Packager: Totally Clear Products, Inc
- 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
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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Aqua Plus Acne Treatment System
daily CLEANSER
Drug Facts
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.
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
refreshing TONER
Drug Facts
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.
spotter GEL
Drug Facts
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.
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
- System Labeling
- Aqua Plus Daily Cleanser
- Aqua Plus Refreshing Toner Label
- Aqua Plus Spotter Gel Label
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INGREDIENTS AND APPEARANCE
AQUA PLUS ACNE TREATMENT SYSTEM
salicylic acid kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:71471-269 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:71471-269-27 1 in 1 BOX; Type 1: Convenience Kit of Co-Package 09/01/2017 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 BOTTLE 50 mL Part 2 1 BOTTLE 30 mL Part 3 1 BOTTLE 50 mL Part 1 of 3 AQUA PLUS DAILY CLEANSER
salicylic acid solutionProduct Information Item Code (Source) NDC:71471-561 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71471-561-27 50 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/01/2017 Part 2 of 3 AQUA PLUS SPOTTER GEL
salicylic acid gelProduct Information Item Code (Source) NDC:71471-312 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 15 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71471-312-27 30 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/01/2017 Part 3 of 3 AQUA PLUS REFRESHING TONER
salicylic acid solutionProduct Information Item Code (Source) NDC:71471-416 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:71471-416-27 50 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/01/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333D 09/01/2017 Labeler - Totally Clear Products, Inc (080687729)