SPL v1
SPL
SPL Set ID 49064b32-0cec-45de-9fe1-44f55edf6d14
Route
TOPICAL
Published
Effective Date 2016-07-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Alcohol Glycerin Trideceth-8 Peg-12 Dimethicone Hamamelis Virginiana Flower Water Edetate Disodium Benzalkonium Chloride Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-07-17

Description

Active ingredient Salicylic acid 2%


Medication Information

Warnings and Precautions

Warnings

For external use only.

Avoid contact with eyes & lip, if contact

occurs, flush throoughly with water.

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 usedunless 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 the skin thoroughly before applying medication

-Use the pad to wipe the entire affected area one to three times daily

-If bothersome dryness or peeling occurs, reduce application to once a day or every other day

-Do not peave pad on skin for an extended period of time.

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  water, SD

alcohol, glycerin, trideceth - 8,

PEG-12 dimethicone, hamamelis virginiana

flower (witch hazel) water, disodium EDTA,

benzalkonium chloride, sodium hydroxide,

fragrance

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 the skin thoroughly before applying medication

-Use the pad to wipe the entire affected area one to three times daily

-If bothersome dryness or peeling occurs, reduce application to once a day or every other day

-Do not peave pad on skin for an extended period of time.

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes & lip, if contact

occurs, flush throoughly with water.

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 usedunless 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  water, SD

alcohol, glycerin, trideceth - 8,

PEG-12 dimethicone, hamamelis virginiana

flower (witch hazel) water, disodium EDTA,

benzalkonium chloride, sodium hydroxide,

fragrance

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

All Sections (JSON)