SPL v3
SPL
SPL Set ID 76cde116-0b13-ffe6-e053-2991aa0a9675
Route
TOPICAL
Published
Effective Date 2018-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Dexpanthenol Ethylhexylglycerin Eucalyptus Oil Xanthan Gum Magnesium Disodium Edta Cocamidopropyl Hydroxysultaine Disodium Laureth Sulfosuccinate Sage Oil Sodium Lauryl Sulfoacetate Witch Hazel Willow Bark Glycerin Isoceteth-20 Phenoxyethanol Pine Needle Oil (pinus Sylvestris) Potassium Sorbate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-26

Description

Active Ingredient: Salicylic Acid (2%)


Medication Information

Warnings and Precautions

WARNING: For External Use Only

Indications and Usage

To cleanse skin and prevent acne

Dosage and Administration

Recommended Use: Use daily both morning and night. Cleanse facial and neck area by massaging a liberal amount onto damp skin using upward circular motions. Rinse thoroughly with warm water.

Description

Active Ingredient: Salicylic Acid (2%)

Section 50565-1

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center.

Section 50567-7

When using this product: using other acne medications at the same time may cause excessive dryness or irritation. Do not use in or near eyes, lips and mouth.

Section 51727-6

Other Ingredients: Cocamidopropyl Hydrosultaine (Scherctaine SCAB), Disodium EDTA, D-Panthenol, Deionized Water, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Eucalyptus Oil, Sage Extract, Witch Hazel, Willow Bark, Glycerin, Isoceteth-20, Phenoxyethanol, Pinus Sylvestre, Potassium Sorbate, Sodium Lauryl Sulfoacetate, Water, Xanthan Gum

Section 51945-4

Section 55105-1

Purpose: acne medication

Section 55106-9

Active Ingredient: Salicylic Acid (2%)


Structured Label Content

Indications and Usage (34067-9)

To cleanse skin and prevent acne

Dosage and Administration (34068-7)

Recommended Use: Use daily both morning and night. Cleanse facial and neck area by massaging a liberal amount onto damp skin using upward circular motions. Rinse thoroughly with warm water.

Warnings and Precautions (34071-1)

WARNING: For External Use Only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, seek medical help or contact a Poison Control Center.

Section 50567-7 (50567-7)

When using this product: using other acne medications at the same time may cause excessive dryness or irritation. Do not use in or near eyes, lips and mouth.

Section 51727-6 (51727-6)

Other Ingredients: Cocamidopropyl Hydrosultaine (Scherctaine SCAB), Disodium EDTA, D-Panthenol, Deionized Water, Disodium Laureth Sulfosuccinate, Ethylhexylglycerin, Eucalyptus Oil, Sage Extract, Witch Hazel, Willow Bark, Glycerin, Isoceteth-20, Phenoxyethanol, Pinus Sylvestre, Potassium Sorbate, Sodium Lauryl Sulfoacetate, Water, Xanthan Gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose: acne medication

Section 55106-9 (55106-9)

Active Ingredient: Salicylic Acid (2%)


Advanced Ingredient Data


Raw Label Data

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