Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 487a7d1c-0f98-4d36-bfe9-c12bcda8d0b3
Route
TOPICAL
Published
Effective Date 2014-05-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (20 mg)
Inactive Ingredients
Lactic Acid, Unspecified Form Niacinamide Dimethicone Yeast Proline Water Alcohol Medium-chain Triglycerides Glycerin Butylene Glycol Sorbitol Cetyl Alcohol Hyaluronate Sodium Ceteth-10 Phosphate Propylene Glycol Glutamine Leucine Serine Hedera Helix Leaf Sambucus Nigra Flower Imperata Cylindrica Root Malva Sylvestris Flowering Top Mentha Piperita Leaf Alchemilla Xanthochlora Flowering Top Arnica Montana Flower Parietaria Officinalis Leaf Phenoxyethanol Ethylhexylglycerin Lavender Oil Carbomer Copolymer Type A Primula Veris Achillea Millefolium Cetostearyl Alcohol Sorbitan Olivate Mangifera Indica Seed Butter Hexylresorcinol Comfrey Root Hexylene Glycol Veronica Officinalis Flowering Top Melissa Officinalis Leaf Gag Salix Alba Bark Oleanolic Acid Cetearyl Olivate Ppg-12/smdi Copolymer Dihexadecyl Phosphate Stearic Acid Glyceryl Monostearate Arctostaphylos Uva-ursi Leaf Peg-60 Almond Glycerides Nordihydroguaiaretic Acid, (+/-)- Peg-100 Stearate Mitracarpus Hirtus Whole Hydrolyzed Wheat Protein (enzymatic, 3000 Mw) Maltodextrin Syringa Vulgaris Whole Xanthan Gum Magnesium Aluminum Silicate Ammonia Edetate Disodium Glycolic Acid Azelaic Acid Hexyl Laurate Alpha-tocopherol Acetate Shea Butter Ethyl Linoleate Plantago Ovata Seed Cucumber Caprylyl Glycol Linalool, (+/-)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-05-30

Description

Active Ingredients: Salicylic Acid 2%


Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

Uses:

For the treatment of acne

Dosage and Administration

Directions

  • Clean the skin thoroughly before before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, stsart with one application daily, then gradually increase to two or three times daily if needed or as directed vy doctor.
  • If bothersome dryness or peeling occurs, reduce applicaiton to ince a day or every other day.
  • Sensitivity Test for a new users. Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follwo the directions atated above.
Description

Active Ingredients: Salicylic Acid 2%

Section 50565-1

Keep out of reach of children.

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

Section 50566-9

If irritation occurs, only use one topical acne medication at a time.

Section 50567-7

When Using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

Section 51727-6

Water (Aqua), Alcohol Denat., Glycolic Acid, Caprylic / Capric Triglyceride, Azelaic Acid, Glycerin, Hexyl Laurate, Cetearyl Alcohol, Cetearyl Olivate, Butylene Glycol, Sorbitol, Lactic Acid, Sorbitan Olivate, PPG-12 /SMDI Copolymer, Niacinamide, Cetyl Alcohol, Sodium Hyaluronate, Dicetyl Phosphate, Ceteth-10 Phosphate, Srearic Acid, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indiaca (Mango) Seed Butter, Dimethicone, Ethyl Linoleate, Hexylrsorcinol, Yeast Ploysaccharides, Propylene Glycol, Symphytum Officinales Rhizome/Root Extract, Plantago Ovata Seed Extract, Glutamine, Proline, Leucine, Serine, Hedera, Helix (Ivy) Leaf/Stem Extract, Cucumis Sativus Fruit Extract, Sambucus Nigra Flower Extract, Arnica Montana Flower Extract, Parietaria Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Lavandula Angustifoia (Lavender) Oil, Imperata Cylindrica (Root) Extract, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Mellifolium Extract, Hydrolyzed Vegetable Protein, Glycosaminoglycans, Salix Alba (Willlow) Bark Extract, Arcaptostaphylos, Uva Ursi Leaf Extract, Mitracarpus Scaber Extract, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid. Glycerin, Hydrolyzed wheat Protein, Hydrolyzed Wheat Starch, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Xanthan Gum, Magnesium Aluminum Silicate, Ammonium Hydroxide, Disodium EDTA, Linalool

Section 51945-4

Manufactured for Dermaquest Inc

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1

Purpose: Acne Treatment

Section 55106-9

Active Ingredients: Salicylic Acid 2%

Section 60561-8

Other Information:

Protect the product in this container from the excessive heat and direct sun.


Structured Label Content

Indications and Usage (34067-9)

Uses:

For the treatment of acne

Dosage and Administration (34068-7)

Directions

  • Clean the skin thoroughly before before applying this product.
  • Cover the entire affected area with a thin layer one to three times daily.
  • Because excessive drying of the skin may occur, stsart with one application daily, then gradually increase to two or three times daily if needed or as directed vy doctor.
  • If bothersome dryness or peeling occurs, reduce applicaiton to ince a day or every other day.
  • Sensitivity Test for a new users. Apply product sparingly to one or two small affected areas during first 3 days. If no discomfort occurs, follwo the directions atated above.
Warnings and Precautions (34071-1)

Warnings:

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children.

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

Section 50566-9 (50566-9)

If irritation occurs, only use one topical acne medication at a time.

Section 50567-7 (50567-7)

When Using this product: Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.

Section 51727-6 (51727-6)

Water (Aqua), Alcohol Denat., Glycolic Acid, Caprylic / Capric Triglyceride, Azelaic Acid, Glycerin, Hexyl Laurate, Cetearyl Alcohol, Cetearyl Olivate, Butylene Glycol, Sorbitol, Lactic Acid, Sorbitan Olivate, PPG-12 /SMDI Copolymer, Niacinamide, Cetyl Alcohol, Sodium Hyaluronate, Dicetyl Phosphate, Ceteth-10 Phosphate, Srearic Acid, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, Butyrospermum Parkii (Shea) Butter, Mangifera Indiaca (Mango) Seed Butter, Dimethicone, Ethyl Linoleate, Hexylrsorcinol, Yeast Ploysaccharides, Propylene Glycol, Symphytum Officinales Rhizome/Root Extract, Plantago Ovata Seed Extract, Glutamine, Proline, Leucine, Serine, Hedera, Helix (Ivy) Leaf/Stem Extract, Cucumis Sativus Fruit Extract, Sambucus Nigra Flower Extract, Arnica Montana Flower Extract, Parietaria Officinalis Extract, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Lavandula Angustifoia (Lavender) Oil, Imperata Cylindrica (Root) Extract, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Malva Sylvestris (Mallow) Extract, Mentha Piperita (Peppermint) Leaf Extract, Primula Veris Extract, Alchemilla Vulgaris Extract, Veronica Officinalis Extract, Melissa Officinalis Leaf Extract, Achillea Mellifolium Extract, Hydrolyzed Vegetable Protein, Glycosaminoglycans, Salix Alba (Willlow) Bark Extract, Arcaptostaphylos, Uva Ursi Leaf Extract, Mitracarpus Scaber Extract, PEG-60 Almond Glycerides, Nordihydroguaiaretic Acid, Oleanolic Acid. Glycerin, Hydrolyzed wheat Protein, Hydrolyzed Wheat Starch, Maltodextrin, Syringa Vulgaris (Lilac) Leaf Cell Culture Extract, Xanthan Gum, Magnesium Aluminum Silicate, Ammonium Hydroxide, Disodium EDTA, Linalool

Section 51945-4 (51945-4)

Manufactured for Dermaquest Inc

Hayward, CA 94544

1272 GK, NL Made in USA

dermaquestinc.com

Section 55105-1 (55105-1)

Purpose: Acne Treatment

Section 55106-9 (55106-9)

Active Ingredients: Salicylic Acid 2%

Section 60561-8 (60561-8)

Other Information:

Protect the product in this container from the excessive heat and direct sun.


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)