Acne Calming Water Cream

Acne Calming Water Cream
SPL v5
SPL
SPL Set ID 01b70e53-9e24-4950-bbe9-c58905b6e68d
Route
TOPICAL
Published
Effective Date 2021-12-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (10 mg)
Inactive Ingredients
Niacinamide Glycerin Silicon Dioxide Propanediol Isododecane Tranexamic Acid Glyceryl Stearate Citrate Alkyl (c12-15) Benzoate N-acetylglucosamine Tromethamine Aluminum Starch Octenylsuccinate Phenoxyethanol Cetostearyl Alcohol Capryloyl Glycine Potassium Cetyl Phosphate Allantoin Xanthan Gum Caprylyl Glycol Ethylhexylglycerin Tocopherol Water Sunflower Oil Edetate Disodium Anhydrous Caprylic Acid Sodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-25

Description

Salicylic Acid 1%

Purpose

Acne Treatment


Medication Information

Purpose

Acne Treatment

Description

Salicylic Acid 1%

Uses
  • For the treatment of acne
  • Helps prevent new acne blemishes
Warnings

For external use only.

Directions

Cleanse the skin thoroughly before applying medication. 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Active Ingredients

Salicylic Acid 1%

Inactive Ingredients

Water (Aqua), Niacinamide, Glycerin, Silica, Propanediol, Isododecane, Tranexamic Acid, Glyceryl Stearate Citrate, C12-15 Alkyl Benzoate, Acetyl Glucosamine, Tromethamine, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Cetearyl Alcohol, Capryloyl Glycine, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflowe) Seed Oil, Disodium EDTA, Caprylic Acid, Sodium Citrate May Contain: Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77492)

Package Labeling:30ml

Package Labeling:50ml

Questions Or Comments

1-888-315-9814

When Using This Product

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.

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • For the treatment of acne
  • Helps prevent new acne blemishes
Purpose

Acne Treatment

Warnings

For external use only.

Directions

Cleanse the skin thoroughly before applying medication. 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. Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs, follow the directions stated eleswhere on this label.

Active Ingredients (Active ingredients)

Salicylic Acid 1%

Inactive Ingredients (Inactive ingredients)

Water (Aqua), Niacinamide, Glycerin, Silica, Propanediol, Isododecane, Tranexamic Acid, Glyceryl Stearate Citrate, C12-15 Alkyl Benzoate, Acetyl Glucosamine, Tromethamine, Aluminum Starch Octenylsuccinate, Phenoxyethanol, Cetearyl Alcohol, Capryloyl Glycine, Potassium Cetyl Phosphate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Allantoin, Xanthan Gum, Caprylyl Glycol, Ethylhexylglycerin, Tocopherol, Helianthus Annuus (Sunflowe) Seed Oil, Disodium EDTA, Caprylic Acid, Sodium Citrate May Contain: Chromium Oxide Greens (CI 77288), Iron Oxides (CI 77492)

Package Labeling:30ml

Package Labeling:50ml

Questions Or Comments (Questions or comments)

1-888-315-9814

When Using This Product (When using this product)

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.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


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