Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 3e8f57ef-21e3-4771-aa99-2a15547b352f
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 Sodium C12-14 Olefin Sulfonate Cocamidopropyl Betaine Glycerin Sodium Chloride Linoleamidopropyl Pg-dimonium Chloride Phosphate Edetate Disodium Butylene Glycol Aloe Vera Leaf Menthol Propylene Glycol Sanguisorba Officinalis Root Chinese Cinnamon Ginger Crithmum Maritimum Himanthalia Elongata Mastocarpus Stellatus Macrocystis Pyrifera

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-04-01

Description

Active Ingredient Salicylic Acid 1.5%...


Medication Information

Warnings and Precautions
For external use only
Indications and Usage

Directions

Wash affected area twice daily

Dosage and Administration


Wash affected area twice daily

When using this product avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

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 or 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

Water (Aqua), Sodium C14-16 Olefin Sulfonate,

Cocamidopropyl Betaine, Glycerin, Sodium Chloride,

Linoleamidopropyl PG-Dimonium Chloride Phosphate,

Fragrance (Parfum), Disodium EDTA, Butylene Glycol,

Aloe Barbadensis Leaf Juice, Menthol, Propylene

Glycol, Poterium Officinale Root Extract,

Cinnamomum Cassia Bark Extract, Zingiber

Officinale (Ginger) Root Extract, Palmaria Palmata

Extract, Crithmum Maritimum Extract, Himanthalia

Elongata Extract, Gigartina Stellata Extract,

Macrocystis Pyrifera Extract, Blue 1 (CI 42090)

Section 51945-4
Image of label aacf247.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)

Directions

Wash affected area twice daily

Dosage and Administration (34068-7)


Wash affected area twice daily

When using this product avoid contact with eyes.

If contact occurs, rinse thoroughly with water.

Warnings and Precautions (34071-1)
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 or 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)

Water (Aqua), Sodium C14-16 Olefin Sulfonate,

Cocamidopropyl Betaine, Glycerin, Sodium Chloride,

Linoleamidopropyl PG-Dimonium Chloride Phosphate,

Fragrance (Parfum), Disodium EDTA, Butylene Glycol,

Aloe Barbadensis Leaf Juice, Menthol, Propylene

Glycol, Poterium Officinale Root Extract,

Cinnamomum Cassia Bark Extract, Zingiber

Officinale (Ginger) Root Extract, Palmaria Palmata

Extract, Crithmum Maritimum Extract, Himanthalia

Elongata Extract, Gigartina Stellata Extract,

Macrocystis Pyrifera Extract, Blue 1 (CI 42090)

Section 51945-4 (51945-4)
Image of label aacf247.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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