Drug Facts

Drug Facts
SPL v14
SPL
SPL Set ID df0a4398-4c21-421a-a7dd-92149b1dc8a6
Route
TOPICAL
Published
Effective Date 2019-10-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.25 g)
Inactive Ingredients
Water Sodium Pyrrolidone Carboxylate Ammonium Lauryl Sulfate Succinic Acid Phosphoric Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-09-07

Description

Active Ingredients Salicylic Acid 0.5% w/w


Medication Information

Warnings and Precautions

Warnings:

For external use only

When using this product

Avoid contact with eyes and mouth.

If contact occurs, rinse thoroughly

with water. Skin irritation and dryness

is more likely to occur if you use

another topical acen medication at

the same time. If irritation occurs,

only use one topical acne medication

at a time. Limit use to face and neck.

Indications and Usage

Uses:  For the treatment of acne

Dosage and Administration

Directions:

Clean the skin thoroughly before

applying e product.

•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 to 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 Ingredients Salicylic Acid 0.5% w/w

Section 44425-7

Other information:

•Store in a cool, dry place

•Do not freeze

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

Inactive Ingredients:

Water, Sodium PCA, Ammonium Lauryl

Sulfate, Succinic Acid, Phospheric Acid.

Section 51945-4

Section 53413-1

Questions or Comments?

[email protected]

Section 55105-1

Purpose:Acne Treatment

Section 55106-9

Active Ingredients

Salicylic Acid 0.5% w/w


Structured Label Content

Indications and Usage (34067-9)

Uses:  For the treatment of acne

Dosage and Administration (34068-7)

Directions:

Clean the skin thoroughly before

applying e product.

•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 to 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

When using this product

Avoid contact with eyes and mouth.

If contact occurs, rinse thoroughly

with water. Skin irritation and dryness

is more likely to occur if you use

another topical acen medication at

the same time. If irritation occurs,

only use one topical acne medication

at a time. Limit use to face and neck.

Section 44425-7 (44425-7)

Other information:

•Store in a cool, dry place

•Do not freeze

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)

Inactive Ingredients:

Water, Sodium PCA, Ammonium Lauryl

Sulfate, Succinic Acid, Phospheric Acid.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or Comments?

[email protected]

Section 55105-1 (55105-1)

Purpose:Acne Treatment

Section 55106-9 (55106-9)

Active Ingredients

Salicylic Acid 0.5% w/w


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)