Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID bd4a44df-a0c2-4eb3-aaf8-dc696293e349
Route
TOPICAL
Published
Effective Date 2011-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 mL)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Sodium C12-15 Pareth-15 Sulfonate Anhydrous Citric Acid Linoleamidopropyl Pg-dimonium Chloride Phosphate Propylene Glycol 1-decene Aloe Vera Leaf Chamaemelum Nobile Flower Chamomile Sodium Chloride Fd&c Blue No. 1 Ext. D&c Violet No. 2

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-03-18

Description

SALICYLIC ACID 2%

Purpose

ACNE TREATMENT


Medication Information

Purpose

ACNE TREATMENT

Description

SALICYLIC ACID 2%

Uses

FOR THE TREATMENT OF ACNE.  HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

Section 51945-4

Warnings

FOR EXTERNAL USE ONLY.

Directions:

Enter section text here

Active Ingredient

SALICYLIC ACID 2%

Inactive Ingredients

WATER, SODIUM LAURETH SULFAE, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, SODIUM C12-15 PARETH-15 SULFONATE, FRAGRANCE, CITRIC ACID, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, PROPYLENE GLYCOL, DECYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, SODIUM CHLORIDE, BLUE 1 (CI 42090), EXT.VIOLET 2 (CI 60730).

When Using This Product

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

USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR RIGHT AFTER USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN.  IF THIS OCCURS, ONLY ONE DRUG SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Keep Out of Reach of Children

Enter section text here

Stop Using This Product and Ask A Doctor If

IRRITATION OR RASH DEVELOPS AND LASTS.


Structured Label Content

Uses (USES)

FOR THE TREATMENT OF ACNE.  HELPS PREVENT THE DEVELOPMENT OF NEW ACNE BLEMISHES.

Section 51945-4 (51945-4)

Purpose (PURPOSE)

ACNE TREATMENT

Warnings (WARNINGS)

FOR EXTERNAL USE ONLY.

Directions: (DIRECTIONS:)

Enter section text here

Active Ingredient (ACTIVE INGREDIENT)

SALICYLIC ACID 2%

Inactive Ingredients (INACTIVE INGREDIENTS)

WATER, SODIUM LAURETH SULFAE, SODIUM C14-16 OLEFIN SULFONATE, COCAMIDOPROPYL BETAINE, SODIUM C12-15 PARETH-15 SULFONATE, FRAGRANCE, CITRIC ACID, LINOLEAMIDOPROPYL PG-DIMONIUM CHLORIDE PHOSPHATE, PROPYLENE GLYCOL, DECYLENE GLYCOL, ALOE BARBADENSIS LEAF EXTRACT, ANTHEMIS NOBILIS FLOWER EXTRACT, CHAMOMILLA RECUTITA (MATRICARIA) FLOWER EXTRACT, SODIUM CHLORIDE, BLUE 1 (CI 42090), EXT.VIOLET 2 (CI 60730).

When Using This Product (WHEN USING THIS PRODUCT)

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

USING OTHER TOPICAL ACNE DRUGS AT THE SAME TIME OR RIGHT AFTER USE OF THIS PRODUCT MAY INCREASE DRYNESS OR IRRITATION OF THE SKIN.  IF THIS OCCURS, ONLY ONE DRUG SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

Enter section text here

Stop Using This Product and Ask A Doctor If (STOP USING THIS PRODUCT AND ASK A DOCTOR IF)

IRRITATION OR RASH DEVELOPS AND LASTS.


Advanced Ingredient Data


Raw Label Data

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