Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 7675a161-a7f9-47cc-9f46-2dd35dd3c5bf
Route
TOPICAL
Published
Effective Date 2017-05-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (9 mg)
Inactive Ingredients
Water Sodium Laureth-3 Sulfate Cocamidopropyl Betaine Sodium Chloride Methylparaben Piroctone Olamine Disodium Laureth Sulfosuccinate Edetate Disodium Peg-120 Methyl Glucose Dioleate Trimethyl Octadecyl Ammonium Chloride Propylene Glycol Guar Hydroxypropyltrimonium Chloride (1.7 Substituents Per Saccharide) Polyquaternium-10 (1000 Mpa.s At 2%) Coco Monoisopropanolamide Dimethicone Laureth-4 Laureth-23 Sodium Benzoate Citric Acid Monohydrate Magnesium Nitrate Methylchloroisothiazolinone Magnesium Chloride Methylisothiazolinone Polyquaternium-68 Laureth-2 Laureth-3 Glycine Serine Alanine Butylene Glycol Amino Acids, Silk Fallopia Multiflora Root Pearl (hyriopsis Cumingii) Caramel

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2017-05-15

Description

Salicylic Acid 1.8%


Medication Information

Warnings and Precautions

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

Indications and Usage

For the relief of symptoms associated with Seborrheic Dermatitis including itching, scaling, flaking, redness and

irritation of the scalp. Helps prevent recurrence

Dosage and Administration

Apply a suitable amount to hair. After massaging gently, leave on scalp for two minutes and rinse with water

Description

Salicylic Acid 1.8%

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 51727-6

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium chloride, Methylparaben, Piroctone Olamine, Disodium Laureth Sulfosuccinate, Disodium EDTA, Salicylic Acid, PEG-120 Methyl Glucose Dioleate, Steartrimonium Chloride, Propylene Glycol, Propylene Glycol, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Cocamide MIPA, Laureth-4, Laureth-23, Sodium Benzoate, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Polyquaternium-68, Laureth-2, Laureth-3, Hydrolyzed Collagen, Propylene Glycol, Glycine, Serine, Alanine, Butylene Glycol, Silk Amino Acids, Bis(C13-15 Alkoxy) PG-Amodimethicone, Polygonum Multiflorum Root Extract, Butylene Glycol, Silt, Pearl Extract, Caramel, Fragrance

Section 51945-4

Section 55105-1

Seborrheic Dermatitis Treatment

Section 55106-9

Salicylic Acid 1.8%


Structured Label Content

Indications and Usage (34067-9)

For the relief of symptoms associated with Seborrheic Dermatitis including itching, scaling, flaking, redness and

irritation of the scalp. Helps prevent recurrence

Dosage and Administration (34068-7)

Apply a suitable amount to hair. After massaging gently, leave on scalp for two minutes and rinse with water

Warnings and Precautions (34071-1)

For external use only

Do not use on damaged or broken skin

Stop using and ask a doctor if rash occurs

When using this product, keep out of eyes. Rinse with water to remove

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 51727-6 (51727-6)

Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium chloride, Methylparaben, Piroctone Olamine, Disodium Laureth Sulfosuccinate, Disodium EDTA, Salicylic Acid, PEG-120 Methyl Glucose Dioleate, Steartrimonium Chloride, Propylene Glycol, Propylene Glycol, Guar Hydroxypropyltrimonium Chloride, Polyquaternium-10, Cocamide MIPA, Laureth-4, Laureth-23, Sodium Benzoate, Citric Acid, Magnesium Nitrate, Methylchloroisothiazolinone, Magnesium Chloride, Methylisothiazolinone, Polyquaternium-68, Laureth-2, Laureth-3, Hydrolyzed Collagen, Propylene Glycol, Glycine, Serine, Alanine, Butylene Glycol, Silk Amino Acids, Bis(C13-15 Alkoxy) PG-Amodimethicone, Polygonum Multiflorum Root Extract, Butylene Glycol, Silt, Pearl Extract, Caramel, Fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Seborrheic Dermatitis Treatment

Section 55106-9 (55106-9)

Salicylic Acid 1.8%


Advanced Ingredient Data


Raw Label Data

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