Aqua Plus Acne Treatment System

Manufacturer
Totally Clear Products, Inc
Effective date
2017-12-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:40

Label at a glance#

ProductAqua Plus Acne Treatment System
Active ingredientSALICYLIC ACID
Label structure5 sections

Label contents#

Full prescribing information#

Aqua Plus Acne Treatment System

SPL UNCLASSIFIED SECTION

daily CLEANSER

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For The Treatment of Acne

Warnings - For External Use Only

WARNINGS SECTION

When Using This Product:

OTC - WHEN USING SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

refreshing TONER

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For The Treatment Of Acne

Warnings - For External Use Only

WARNINGS SECTION

When Using This Product:

OTC - WHEN USING SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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

STORAGE AND HANDLING SECTION

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

spotter GEL

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

For The Treatment Of Acne

Warnings - For External Use Only

WARNINGS SECTION

When Using This Product:

OTC - WHEN USING SECTION

  • 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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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.

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

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

System Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

System LabelSystem Label

Aqua Plus Daily Cleanser

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Daily Cleanser LabelDaily Cleanser Label

Aqua Plus Refreshing Toner Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Refreshing Toner LabelRefreshing Toner Label

Aqua Plus Spotter Gel Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Spotter GelSpotter Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1943754{1 (30 ML) (salicylic acid 0.015 MG/MG Topical Gel) / 1 (50 ML) (salicylic acid 10 MG/ML Topical Solution) / 1 (50 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } PackGPCK3
1047362salicylic acid 1 % Topical SolutionPSN3
1943754salicylic acid 1 % Topical Solution (50 mL) / salicylic acid 1.5 % Topical Gel (30 mL) / salicylic acid 2 % Medicated Liquid Soap (50 mL) PackPSN3
416212salicylic acid 1.5 % Topical GelPSN3
562600salicylic acid 2 % Medicated Liquid SoapPSN3
416212salicylic acid 0.015 MG/MG Topical GelSCD3
1047362salicylic acid 10 MG/ML Topical SolutionSCD3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
1047362salicylic acid 1 % Topical SolutionSY3
1943754salicylic acid 1 % Topical Solution (50 ML) / salicylic acid 1.5 % Topical Gel (30 ML) / salicylic acid 2 % Medicated Liquid Soap (50 ML) PackSY3
416212salicylic acid 1.5 % Topical GelSY3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71471-269-272020-01-31C16284748780-19d75b9d0-42dc-f424-e053-dadaa90a57ce2774453d-170e-4dca-96e2-60bdee79d28a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71471-269-27Aqua Plus Acne Treatment System1 in 1 BOXKIT13
71471-312-27Aqua Plus Acne Treatment System30 mL in 1 BOTTLEGEL30 mL15 mg in 1mL3
71471-416-27Aqua Plus Acne Treatment System50 mL in 1 BOTTLESOLUTION50 mL10 mg in 1mL3
71471-561-27Aqua Plus Acne Treatment System50 mL in 1 BOTTLESOLUTION50 mL20 mg in 1mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71471-269AQUA PLUS ACNE TREATMENT SYSTEM (SALICYLIC ACID) KIT [TOTALLY CLEAR PRODUCTS, INC]3Legacy NDC, 4 package rows20171224_2774453d-170e-4dca-96e2-60bdee79d28a.zip
71471-312AQUA PLUS ACNE TREATMENT SYSTEM (SALICYLIC ACID) KIT [TOTALLY CLEAR PRODUCTS, INC]3Unmatched20171224_2774453d-170e-4dca-96e2-60bdee79d28a.zip
71471-416AQUA PLUS ACNE TREATMENT SYSTEM (SALICYLIC ACID) KIT [TOTALLY CLEAR PRODUCTS, INC]3Unmatched20171224_2774453d-170e-4dca-96e2-60bdee79d28a.zip
71471-561AQUA PLUS ACNE TREATMENT SYSTEM (SALICYLIC ACID) KIT [TOTALLY CLEAR PRODUCTS, INC]3Unmatched20171224_2774453d-170e-4dca-96e2-60bdee79d28a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 38 matching rows.

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 54 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
610897df-2781-a1c7-e053-2991aa0ae3502774453d-170e-4dca-96e2-60bdee79d28a2017-12-23WarningsExact identifier
spl id: 610897df-2781-a1c7-e053-2991aa0ae350
spl set id: 2774453d-170e-4dca-96e2-60bdee79d28a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.