SPL v1
SPL
SPL Set ID 88839b28-0c4f-4eef-a125-494b7e0a8889
Route
TOPICAL
Published
Effective Date 2014-07-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Sodium C14-16 Olefin Sulfonate Sodium Laureth Sulfate Cocamidopropyl Betaine Sodium Lauryl Sulfoacetate Peg-150 Distearate Phenoxyethanol Methylisothiazolinone Aminomethylpropanol Sodium Chloride Glycerin Allantoin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-06-13

Description

ACTIVE INGREDIENT SALICYLIC ACID 2%


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration

DIRECTIONS

  • USE MORNING AND NIGHT.
  • WET AREA TO BE CLEANSED.
  • APPLY ACNE TREATMENT ND GENTLY MASSAGE AREA FOR 1-2 MINUTES..
  • RINSE THOROUGHLY AND PAT DRY.
  • RINSE THOROUGHLY WITH WATER..
Description

ACTIVE INGREDIENT SALICYLIC ACID 2%

Section 50565-1

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9

STOP USE ND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
Section 50568-5

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF TH SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1

DO NOT USE IF YOU HAVE  KNOWN ALLERGY TO SALICYLIC ACID OR ASPERIN.

Section 51727-6

INACTIVE INGREDIENTS

WATER, SODIUM C14-16 OLEFIN SULFONATE, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFOACETATE, PEG-150 DISTEARATE, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, AMINOMETHYL PROPANOL, SODIUM CHLORIDE, GLYCERIN, ALLANTOIN

Section 51945-4

Section 53413-1

QUESTIONS OR COMMENTS? 1-877-445-4624

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID 2%


Structured Label Content

Indications and Usage (34067-9)

USE

FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)

DIRECTIONS

  • USE MORNING AND NIGHT.
  • WET AREA TO BE CLEANSED.
  • APPLY ACNE TREATMENT ND GENTLY MASSAGE AREA FOR 1-2 MINUTES..
  • RINSE THOROUGHLY AND PAT DRY.
  • RINSE THOROUGHLY WITH WATER..
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN. IF PRODUCT IS SWALLOWED, GET MEDICL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

Section 50566-9 (50566-9)

STOP USE ND ASK A DOCTOR IF SKIN IRRITATION OCCURS.

  • AVOID CONTACT WITH THE EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER.
  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN.
Section 50568-5 (50568-5)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING USE OF THIS PRODUCT. THIS MAY INCREASE DRYNESS OR IRRITATION OF TH SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1 (50570-1)

DO NOT USE IF YOU HAVE  KNOWN ALLERGY TO SALICYLIC ACID OR ASPERIN.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

WATER, SODIUM C14-16 OLEFIN SULFONATE, SODIUM LAURETH SULFATE, COCAMIDOPROPYL BETAINE, SODIUM LAURYL SULFOACETATE, PEG-150 DISTEARATE, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, AMINOMETHYL PROPANOL, SODIUM CHLORIDE, GLYCERIN, ALLANTOIN

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS? 1-877-445-4624

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)