SPL v2
SPL
SPL Set ID 99b45eef-216f-40fc-9b86-68597a6804fd
Route
TOPICAL
Published
Effective Date 2013-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water Sodium Laureth Sulfate Sodium Cocoamphoacetate Glycerin Lauryl Glucoside Sodium Cocoyl Glutamate Sodium Lauryl Glycol Carboxylate Arbutin Kojic Acid Ascorbic Acid Sodium Pyrrolidone Carboxylate Allantoin Panthenol Peg-150 Distearate Phenoxyethanol Aminomethylpropanol Methylisothiazolinone

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
  • APPLY A DIME-SIZED AMOUNT, ADD WATER AND LATHER IN HAND
  • APPLY TO FACE
  • GENTLY MASSAGE
  • 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 AND 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 THE SKIN. IF THIS OCCURS, ONLY ONE MEDICATION SHOULD BE USED UNLESS DIRECTED BY A DOCTOR.

Section 50570-1

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

Section 51727-6

INACTIVE INGREDIENTS

Water, Sodium Laureth Sulfate, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Arbutin, Kojic Acid, Ascorbic Acid, Sodium PCA, Allantoin, Panthenol, PEG-150 Distearate, Phenoxyethanol, Aminomethyl Propanol, Methylisothiazolinone, Fragrance

Section 51945-4

Section 53413-1

QUESTIONS OR COMMENTS? 1-877-445-4624  MON-FRI  8AM - 5PM (PST)

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
  • APPLY A DIME-SIZED AMOUNT, ADD WATER AND LATHER IN HAND
  • APPLY TO FACE
  • GENTLY MASSAGE
  • 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 AND 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 THE 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 A KNOWN SENSITIVITY TO SALICYLIC ACID OR ASPERIN.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

Water, Sodium Laureth Sulfate, Sodium Cocoamphoacetate, Glycerin, Lauryl Glucoside, Sodium Cocoyl Glutamate, Sodium Lauryl Glucose Carboxylate, Arbutin, Kojic Acid, Ascorbic Acid, Sodium PCA, Allantoin, Panthenol, PEG-150 Distearate, Phenoxyethanol, Aminomethyl Propanol, Methylisothiazolinone, Fragrance

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS? 1-877-445-4624  MON-FRI  8AM - 5PM (PST)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID 2%


Advanced Ingredient Data


Raw Label Data

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