Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3f9eaff2-ad55-43fc-be1f-2a65516f777e
Route
TOPICAL
Published
Effective Date 2011-10-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (15 uL)
Inactive Ingredients
Water Alcohol Hamamelis Virginiana Bark Butylene Glycol Glycerin Glycolic Acid Sodium Lactate Linoleamidopropyl Pg-dimonium Chloride Phosphate Hydroxyethyl Cellulose (2000 Cps At 1%) Sodium Hydroxide Polysorbate 20 Polyquaternium-10 (400 Cps At 2%) Linalool, (+/-)- Propylene Glycol Sea Salt Dulse Crithmum Maritimum Himanthalia Elongata Mastocarpus Stellatus Macrocystis Pyrifera Zinc Sulfate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2010-03-01

Description

Active Ingredient Salicylic Acid 1.5%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Indications and Usage

When using this product avoid contact

with eyes. If contact occurs, rinse

thoroughly with water.

Dosage and Administration

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.

Description

Active Ingredient Salicylic Acid 1.5%

Section 50565-1

Keep out of reach of children. If

swallowed, get medical help or contact

a Poison Control Center right away. If

excessive skin irritation develops or

increases, discontinue use and consult

a doctor.

Section 50568-5

Ask a doctor of pharmacist before use

if you are using other topical acne

medications at the same time or

immediately following use of this product.

This may increase dryness or irritation of

skin. If this occurs, only one medication

should be used unless directed by a doctor.

Section 51727-6

Inactive Ingredients

Water (Aqua), SD Alcohol 40-B, Hamamelis

Virginiana (Witch Hazel) Bark/Leaf/Twig

Extract, Butylene Glycol, Glycerin, Glycolic

Acid, Sodium Lactate, Linoleamidopropyl

PG-Dimonium Chloride Phosphate,

Hydroxyethylcellulose, Sodium Hydroxide,

Fragrance (Parfum), Polysorbate 20,

Polyquaternium-10, Hydrolyzed Algin,

Linalool, Propylene Glycol, Sea Salt (Maris

Sal), Palmaria Palmata Extract, Crithmum

Maritimum Extract, Himanthalia Elongata

Extract, Gigartina Stellata Extract,

Macrocystis Pyrifera Extract, Zinc Sulfate

Section 51945-4

picture of carton label aacc272.jpg

Section 53413-1

Questions? call 1-800-242-2284

M-F, 8am-6pm CST

Section 55105-1

 Purpose

acne treatment

Section 55106-9

Active Ingredient

Salicylic Acid 1.5%


Structured Label Content

Indications and Usage (34067-9)

When using this product avoid contact

with eyes. If contact occurs, rinse

thoroughly with water.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Section 50565-1 (50565-1)

Keep out of reach of children. If

swallowed, get medical help or contact

a Poison Control Center right away. If

excessive skin irritation develops or

increases, discontinue use and consult

a doctor.

Section 50568-5 (50568-5)

Ask a doctor of pharmacist before use

if you are using other topical acne

medications at the same time or

immediately following use of this product.

This may increase dryness or irritation of

skin. If this occurs, only one medication

should be used unless directed by a doctor.

Section 51727-6 (51727-6)

Inactive Ingredients

Water (Aqua), SD Alcohol 40-B, Hamamelis

Virginiana (Witch Hazel) Bark/Leaf/Twig

Extract, Butylene Glycol, Glycerin, Glycolic

Acid, Sodium Lactate, Linoleamidopropyl

PG-Dimonium Chloride Phosphate,

Hydroxyethylcellulose, Sodium Hydroxide,

Fragrance (Parfum), Polysorbate 20,

Polyquaternium-10, Hydrolyzed Algin,

Linalool, Propylene Glycol, Sea Salt (Maris

Sal), Palmaria Palmata Extract, Crithmum

Maritimum Extract, Himanthalia Elongata

Extract, Gigartina Stellata Extract,

Macrocystis Pyrifera Extract, Zinc Sulfate

Section 51945-4 (51945-4)

picture of carton label aacc272.jpg

Section 53413-1 (53413-1)

Questions? call 1-800-242-2284

M-F, 8am-6pm CST

Section 55105-1 (55105-1)

 Purpose

acne treatment

Section 55106-9 (55106-9)

Active Ingredient

Salicylic Acid 1.5%


Advanced Ingredient Data


Raw Label Data

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