AQUA PLUS ACNE TREATMENT SYSTEM- salicylic acid kit

Aqua Plus Acne Treatment System by

Drug Labeling and Warnings

Aqua Plus Acne Treatment System by is a Otc medication manufactured, distributed, or labeled by Totally Clear Products, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Aqua Plus Daily Cleanser

Aqua Plus Refreshing Toner Label

Aqua Plus Spotter Gel Label

INGREDIENTS AND APPEARANCE

AQUA PLUS ACNE TREATMENT SYSTEM 
salicylic acid kit

Product 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 solution

Product 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 gel

Product 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 solution

Product 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)