SPL v3
SPL
SPL Set ID 35bcdb22-550e-b27c-e063-6294a90a2e5b
Route
TOPICAL
Published
Effective Date 2025-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Juniper Berry Polysorbate 20 Methylpropanediol Sodium Hydroxide Decyl Glucoside Menthyl Lactate Limosilactobacillus Fermentum Cucumis Sativus (cucumber) Fruit Lauryl Glucoside Citric Acid Lactic Acid Salix Purpurea Bark

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-05-23

Description

SALICYLIC ACID 2%

Purpose

ACNE TREATMENT


Medication Information

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2%

Uses

FOR THE TREATMENT OF ACNE. CLEARS ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

Label

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Warnings

FOR EXTERNAL USE ONLY



WHEN USING THIS PRODUCT SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. iF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME

AVOID CONTACT WITH EYES. IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.

Directions

SHAKE WELL BEFORE USE. CLEANSE SKIN THOROUGHLY BEFORE APPLYING THIS 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 OR 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.

Questions?

OLEHENRIKSEN.COM

Active Ingredient

SALICYLIC ACID 2%

Other Information

STORE AT ROOM TEMPERATURE.

Inactive Ingredients

WATER, JUNIPERUS COMMUNIS FRUIT EXTRACT, POLYSORBATE 20, METHYLPROPANEDIOL, LACTOBACILLUS/SALIX PURPUREA BARK FERMENT EXTRACT, BUTYLENE GLYCOL, GLYCERIN, SODIUM HYDROXIDE, DECYL GLUCOSIDE, MENTHYL LACTATE, LACTOBACILLUS FERMENT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, LAURYL GLUCOSIDE, CITRIC ACID, LACTIC ACID.


Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE. CLEARS ACNE BLEMISHES AND ALLOWS SKIN TO HEAL. HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

Label (LABEL)

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF SWALLOWED GET MEICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY



WHEN USING THIS PRODUCT SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. iF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME

AVOID CONTACT WITH EYES. IF EYE CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.

Directions (DIRECTIONS)

SHAKE WELL BEFORE USE. CLEANSE SKIN THOROUGHLY BEFORE APPLYING THIS 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 OR 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.

Questions? (QUESTIONS?)

OLEHENRIKSEN.COM

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2%

Other Information (OTHER INFORMATION)

STORE AT ROOM TEMPERATURE.

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, JUNIPERUS COMMUNIS FRUIT EXTRACT, POLYSORBATE 20, METHYLPROPANEDIOL, LACTOBACILLUS/SALIX PURPUREA BARK FERMENT EXTRACT, BUTYLENE GLYCOL, GLYCERIN, SODIUM HYDROXIDE, DECYL GLUCOSIDE, MENTHYL LACTATE, LACTOBACILLUS FERMENT, CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT, LAURYL GLUCOSIDE, CITRIC ACID, LACTIC ACID.


Advanced Ingredient Data


Raw Label Data

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