Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID ee4224cb-6e17-496d-8dc9-47dcfc3c5c4a
Route
TOPICAL
Published
Effective Date 2016-01-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Alcohol Ammonia Benzalkonium Chloride Butylene Glycol Dimethicone Edetate Disodium Glycerin Hamamelis Virginiana Top Laureth-7 Methyl Lactate, (-)- Paraffin Phenoxyethanol Polyacrylamide (1300000 Mw) Purslane Propylene Glycol Water Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-01-11

Description

Active ingredient Salicylic acid  2%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Ask a doctor or pharmacist before using other topical

acne medications at the same time or immediately

following use of this product. May increase dryness or

irritation of the skin. If this occurs, only one medication

should be used unless directed by a doctor.

When using this product apply to affected area only.

Do not use on broken skin or apply to large areas of the

body.

Indications and Usage

Uses  for the treatment of acne

Dosage and Administration

Directions

-Cleanse skin thoroughly before applying.

-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 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  2%

Section 44425-7

Other information store at room

temperature 68 - 86 F (20 - 30 C)

Section 50565-1

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right

away.

Section 51727-6

Inactive ingredients  alcohol, ammonia,

benzalkonium chloride, butylene glycol, dimethicone,

disodium EDTA, glycerin, hamamelis virginiana extract,

laureth-7, menthyl lactate, paraffin, phenoxyethanol,

polyacrylamide, portaluca oleracea extract, propylene

glycol, water, xanthan gum

Section 51945-4

Section 55105-1

Purpose

Acne treatment

Section 55106-9

Active ingredient

Salicylic acid  2%


Structured Label Content

Indications and Usage (34067-9)

Uses  for the treatment of acne

Dosage and Administration (34068-7)

Directions

-Cleanse skin thoroughly before applying.

-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 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.

Flammable. Keep away from fire or flame.

Ask a doctor or pharmacist before using other topical

acne medications at the same time or immediately

following use of this product. May increase dryness or

irritation of the skin. If this occurs, only one medication

should be used unless directed by a doctor.

When using this product apply to affected area only.

Do not use on broken skin or apply to large areas of the

body.

Section 44425-7 (44425-7)

Other information store at room

temperature 68 - 86 F (20 - 30 C)

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get

medical help or contact a Poison Control Center right

away.

Section 51727-6 (51727-6)

Inactive ingredients  alcohol, ammonia,

benzalkonium chloride, butylene glycol, dimethicone,

disodium EDTA, glycerin, hamamelis virginiana extract,

laureth-7, menthyl lactate, paraffin, phenoxyethanol,

polyacrylamide, portaluca oleracea extract, propylene

glycol, water, xanthan gum

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose

Acne treatment

Section 55106-9 (55106-9)

Active ingredient

Salicylic acid  2%


Advanced Ingredient Data


Raw Label Data

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