SPL v1
SPL
SPL Set ID eb4f8fd3-48f9-4e62-9942-1878217134b4
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 Glycerin Cetostearyl Alcohol Ppg-15 Stearyl Ether Ethylhexyl Palmitate Polysorbate 60 Steareth-21 Potassium Cetyl Phosphate Xanthan Gum Edetate Disodium Methanol, (((1-methyl-2-(5-methyl-3-oxazolidinyl)ethoxy)methoxy)methoxy)- 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 thoroughly 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

-Wet face, squeeze into hands and apply to face

-Gently massage all over face avoiding eye area

-Rinse thoroughly with water

-Recommended for daily use

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, cetearyl alcohol, glycerin,

ppg-15 stearyl ether, ethylhexyl palmitate, steareth-21, potassium

cetyl phosphate, polysorbate 60, xanthan gum, disodium EDTA,

methanol, 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

-Wet face, squeeze into hands and apply to face

-Gently massage all over face avoiding eye area

-Rinse thoroughly with water

-Recommended for daily use

Warnings and Precautions (34071-1)

Warnings

For external use only.

Avoid contact with eyes & lip, if contact

occurs, flush thoroughly 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, cetearyl alcohol, glycerin,

ppg-15 stearyl ether, ethylhexyl palmitate, steareth-21, potassium

cetyl phosphate, polysorbate 60, xanthan gum, disodium EDTA,

methanol, 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)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:08.616353 · Updated: 2026-03-14T22:54:23.335310