SPL v6
SPL
SPL Set ID 8e36c36f-aa9e-4ae2-8dea-53d167e81a7f
Route
TOPICAL
Published
Effective Date 2012-09-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (2 g)
Inactive Ingredients
Water 1,3-butylene Glycol Glycolic Acid Polyquaternium-10 (400 Cps At 2%) Eucalyptus Globulus Leaf Glycyrrhiza Glabra Acetyl Carboxymethyl Cocoyl Glycine Myristoyl Tetrapeptide-4 Hydroxyphenyl Propamidobenzoic Acid Pentylene Glycol Potassium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-09-24

Description

ACTIVE INGREDIENTS 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 AM/PM. AFTER CLEANSING, GENTLY APPLY TO FACE OR AFFECTED AREAS.
  • BECAUSE EXCESSIVE DRYING OF THE FACE MAY OCCUR, START WITH ONE APPLICATION 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.
Description

ACTIVE INGREDIENTS SALICYLIC ACID 2%

Section 50565-1

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

Section 50567-7

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
  • KEEP AWAY FROM LIPS AND MOUTH.
Section 50568-5

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

  • PREGNANT OR LACTATING.
  • YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

Section 51727-6

INACTIVE INGREDIENTS: WATER, BUTYLENE GLYCOL, GLYCOLIC ACID, POLYQUATERNIUM 10, EUCALYPTUS GLOBULUS OIL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ACETYL CARBOXYMETHYL COCOYL GLYCINE, MYRISTOYL TETRAPEPTIDE-13, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, PENTYLENE GLYCOL, POTASSIUM HYDROXIDE.

Section 51945-4

Section 53413-1

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENTS

SALICYLIC ACID 2%

Section 60561-8

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).


Structured Label Content

Indications and Usage (34067-9)

USE FOR THE TREATMENT OF ACNE

Dosage and Administration (34068-7)

DIRECTIONS

  • USE AM/PM. AFTER CLEANSING, GENTLY APPLY TO FACE OR AFFECTED AREAS.
  • BECAUSE EXCESSIVE DRYING OF THE FACE MAY OCCUR, START WITH ONE APPLICATION 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.
Warnings and Precautions (34071-1)

WARNINGS

FOR EXTERNAL USE ONLY

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 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH THOROUGHLY WITH WATER.
  • KEEP AWAY FROM LIPS AND MOUTH.
Section 50568-5 (50568-5)

ASK A DOCTOR OR PHARMACIST BEFORE USE IF

  • PREGNANT OR LACTATING.
  • YOU ARE USING OTHER TOPICAL ACNE MEDICATIONS AT THE SAME TIME OR IMMEDIATELY FOLLOWING THE 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 VERY SENSITIVE SKIN OR ARE SENSITIVE TO SALICYLIC ACID.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS: WATER, BUTYLENE GLYCOL, GLYCOLIC ACID, POLYQUATERNIUM 10, EUCALYPTUS GLOBULUS OIL, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, ACETYL CARBOXYMETHYL COCOYL GLYCINE, MYRISTOYL TETRAPEPTIDE-13, HYDROXYPHENYL PROPAMIDOBENZOIC ACID, PENTYLENE GLYCOL, POTASSIUM HYDROXIDE.

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

QUESTIONS OR COMMENTS?

CALL 877.423.1314 * WWW.LOVEMYBODY.COM

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENTS

SALICYLIC ACID 2%

Section 60561-8 (60561-8)

OTHER INFORMATION

* AVOID STORAGE AT EXTREME TEMPERATURES (BELOW 40°F AND ABOVE 100°F).


Advanced Ingredient Data


Raw Label Data

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