Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bcf22bd6-2aef-4fb5-97ed-17e2217828fc
Route
TOPICAL
Published
Effective Date 2016-01-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Cetostearyl Alcohol Microcrystalline Wax Paraffin Polysorbate 60 Steareth-21 Aloe Vera Leaf Propylene Glycol Jojoba Oil, Randomized Xanthan Gum Menthyl Lactate, (-)-

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

-Wet face   -Gently massage all over face 20-30

seconds, avoiding eye area    -Rinse thoroughly and pat dry

-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,

microcrystalline wax, paraffin, polysorbate 60, steareth-21,

aloe barbadensis leaf juice, propylene glycol, jojoba esters,

xanthan gum, menthyl lactate, ultramarines (blue)



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   -Gently massage all over face 20-30

seconds, avoiding eye area    -Rinse thoroughly and pat dry

-Recommended for daily use

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  water, cetearyl alcohol,

microcrystalline wax, paraffin, polysorbate 60, steareth-21,

aloe barbadensis leaf juice, propylene glycol, jojoba esters,

xanthan gum, menthyl lactate, ultramarines (blue)



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: 2026-02-15T11:56:03.011512 · Updated: 2026-03-14T22:54:14.381059