SPL v7
SPL
SPL Set ID 6157c9c6-f252-5b49-e053-2991aa0ad8ed
Route
TOPICAL
Published
Effective Date 2017-12-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Alcohol 95% Citral Coco-betaine Citric Acid Monohydrate Water Disodium Cocoyl Glutamate Sodium Chloride Cocamidopropyl Betaine Glycerin Hamamelis Virginiana Top Water Phenoxyethanol Azadirachta Indica Leaf Bergamot Oil Peppermint Oil Potassium Sorbate Camellia Sinensis Whole Tert-butylbenzoic Acid (mixed Isomers) Willow Bark Dehydroacetic Acid Sodium Benzoate Orange Peel Melissa Officinalis Leaf Parsley Oil Urtica Dioica Leaf Limonene, (+)- Linalool, (+)-

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-11-29

Description

ACTIVE INGREDIENTS Salicylic Acid 2.0%


Medication Information

Warnings and Precautions

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs,only one drug should be used unless directed by a doctor.

Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

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

Indications and Usage

  • For the treatment of acne
Dosage and Administration

Apply to wet face and massage into a foamy lather. Rinse throughly. Use tvice a day.For best results follow with Alba Botanica Deep Clean Astrigen.

Description

ACTIVE INGREDIENTS Salicylic Acid 2.0%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

Section 51727-6

Water (Aqua), Coco-Betaine, Disodium Cocoyl Glutamate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Piperita (Peppermint) Oil, Azadirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), Carum Petroselinum (Parsley) Extract, Hamamelis Virginiana (Witch Hazel) Water, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract (1), Urtica Dioica (Nettle) Extract, Alcohol (1), Citric Acid, Dehydroacetic Acid, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool

(1) Cerified Organic Ingredient

Section 51945-4

Section 55105-1

Acne Treatment

Section 55106-9

ACTIVE INGREDIENTS

Salicylic Acid 2.0%


Structured Label Content

Indications and Usage (34067-9)

  • For the treatment of acne
Dosage and Administration (34068-7)

Apply to wet face and massage into a foamy lather. Rinse throughly. Use tvice a day.For best results follow with Alba Botanica Deep Clean Astrigen.

Warnings and Precautions (34071-1)

For external use only. Using other topical acne medications at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs,only one drug should be used unless directed by a doctor.

Avoid direct contact with eyes. If contact occurs, flush thoroughly with water.

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.

Section 51727-6 (51727-6)

Water (Aqua), Coco-Betaine, Disodium Cocoyl Glutamate, Sodium Chloride, Cocamidopropyl Betaine, Glycerin, Citrus Aurantium Bergamia (Bergamot) Fruit Oil, Citrus Aurantium Dulcis (Orange) Peel Oil, Mentha Piperita (Peppermint) Oil, Azadirachta Indica Leaf Extract (1), Camellia Sinensis Leaf Extract (1), Carum Petroselinum (Parsley) Extract, Hamamelis Virginiana (Witch Hazel) Water, Melissa Officinalis Leaf Extract, Salix Alba (Willow) Bark Extract (1), Urtica Dioica (Nettle) Extract, Alcohol (1), Citric Acid, Dehydroacetic Acid, Benzoic Acid, Phenoxyethanol, Potassium Sorbate, Sodium Benzoate, Citral, Limonene, Linalool

(1) Cerified Organic Ingredient

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Acne Treatment

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

Salicylic Acid 2.0%


Advanced Ingredient Data


Raw Label Data

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