SPL v3
SPL
SPL Set ID 8200b344-b1c3-42a4-9d30-86852976118c
Route
TOPICAL
Published
Effective Date 2013-06-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Salicylic Acid (0.02 g)
Inactive Ingredients
Aloe Vera Leaf Caprylyl Glycol Anhydrous Citric Acid Edetate Disodium Witch Hazel Lauryl Glucoside Menthol Phenoxyethanol Ppg-5-ceteth-20 Dimethicone Sodium Borate Sodium Citrate Sodium Lauryl Glycol Carboxylate Water

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

  • GENTLY WIPE THE ENTIRE AFFECTED AREA WITH A PAD ONE TO THREE TIMES DAILY.
  • DO NOT RINSE.
  • BECAUSE EXCESSIVE DRYING OF THE SKIN CAN OCCUR, START WITH ONE APPLICATION DAILY, THENGRADUALLY INCREASE TO TWO TO THREE TIMES DAILY IF NEEDED AS DIRECTED BY A DOCTOR.
  • IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE A DAY OR EVERY OTHER DAY.
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.

Section 50567-7

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER
  • KEEP AWAY FROM LIPS AND MOUTH.
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 THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN.

Section 51727-6

INACTIVE INGREDIENTS

ALOE BARBADENSIS LEAF EXTRACT (ALOE EXTRACT), CAPRYLYL GLYCOL, CITRIC ACID, DISODIUM EDTA, FRAGRANCE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, LAURYL GLUCOSIDE, MENTHOL, PHENOXYETHANOL, PPG-5-CETETH-20, SIMETHICNE, SODIUM BORATE, SODIUM CITRATE, SODIUM LAURYL GLUCOSE CARBOXYLATE, WATER

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

  • GENTLY WIPE THE ENTIRE AFFECTED AREA WITH A PAD ONE TO THREE TIMES DAILY.
  • DO NOT RINSE.
  • BECAUSE EXCESSIVE DRYING OF THE SKIN CAN OCCUR, START WITH ONE APPLICATION DAILY, THENGRADUALLY INCREASE TO TWO TO THREE TIMES DAILY IF NEEDED 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 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.

Section 50567-7 (50567-7)

WHEN USING THIS PRODUCT

  • AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE THOROUGHLY WITH WATER
  • KEEP AWAY FROM LIPS AND MOUTH.
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 THIS MEDICATION IF YOU HAVE VERY SENSITIVE SKIN.

Section 51727-6 (51727-6)

INACTIVE INGREDIENTS

ALOE BARBADENSIS LEAF EXTRACT (ALOE EXTRACT), CAPRYLYL GLYCOL, CITRIC ACID, DISODIUM EDTA, FRAGRANCE, HAMAMELIS VIRGINIANA (WITCH HAZEL) EXTRACT, LAURYL GLUCOSIDE, MENTHOL, PHENOXYETHANOL, PPG-5-CETETH-20, SIMETHICNE, SODIUM BORATE, SODIUM CITRATE, SODIUM LAURYL GLUCOSE CARBOXYLATE, WATER

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

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