SPL v2
SPL
SPL Set ID 9517fc1d-8cf7-4d83-b3fc-efdfe927a358
Route
TOPICAL
Published
Effective Date 2013-02-23
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 Cocamidopropyl Betaine Sodium Lauroyl 1-methyl Isethionate Peg-120 Methyl Glucose Dioleate Allantoin Panthenol Oat Angelica Sinensis Whole Glycerin Cocamidopropyl Pg-dimonium Chloride Phosphate Polyquaternium-10 (400 Cps At 2%) Menthol Lecithin, Soybean Anhydrous Citric Acid Butylene Glycol Ethylhexylglycerin Edetate Disodium Phenoxyethanol Potassium Sorbate Methylchloroisothiazolinone Methylisothiazolinone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2013-02-21

Description

ACTIVE INGREDIENT SALICYLIC ACID 2%


Medication Information

Warnings and Precautions

WARNINGS

FOR EXTERNAL USE ONLY

Indications and Usage

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration

DIRECTIONS

  • Squeeze a small amount into the palm of your hand and create a slight lather using cool or warm water.
  • Gently massage the lather over your face for approximately 30 seconds.
  • Avoid the delicate eye area. Rinse thoroughly.
  • Consult your physician before use.
Description

ACTIVE INGREDIENT 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 50566-9

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN RRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50570-1

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
Section 51727-6

INGREDIENTS

aqua (water), sodium C14-16 olefin sulfonate cocamidopropyl betaine , sodium lauroyl methyl isethionate, PEG-120 distearate, allantoin, panthenol, avena sativa (oat) kernel extract, angelica sinensis extract, glycerin, cocamidopropyl PG-dimonium, chloride phosphate, polyquaternium-10, menthol, lecithin, citric acid, butylene glycol, ethylhexylglycerin, disodium EDTA, phenoxyethanol, potassium sorbate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

Section 51945-4

Section 55105-1

PURPOSE

ACNE TREATMENT

Section 55106-9

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8

Other Information

Store at 15-30°C (59-86°F)


Structured Label Content

Indications and Usage (34067-9)

USES

  • TREATS ACNE
  • DRIES UP ACNE PIMPLES
  • HELPS PREVENT NEW ACNE PIMPLES
Dosage and Administration (34068-7)

DIRECTIONS

  • Squeeze a small amount into the palm of your hand and create a slight lather using cool or warm water.
  • Gently massage the lather over your face for approximately 30 seconds.
  • Avoid the delicate eye area. Rinse thoroughly.
  • Consult your physician before use.
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 50566-9 (50566-9)

STOP USE AND ASK A DOCTOR IF TOO MUCH SKIN RRITATION OR SENSITIVITY DEVELOPS OR INCREASES.

Section 50570-1 (50570-1)

DO NOT USE

  • IF YOU HAVE VERY SENSITIVE SKIN
Section 51727-6 (51727-6)

INGREDIENTS

aqua (water), sodium C14-16 olefin sulfonate cocamidopropyl betaine , sodium lauroyl methyl isethionate, PEG-120 distearate, allantoin, panthenol, avena sativa (oat) kernel extract, angelica sinensis extract, glycerin, cocamidopropyl PG-dimonium, chloride phosphate, polyquaternium-10, menthol, lecithin, citric acid, butylene glycol, ethylhexylglycerin, disodium EDTA, phenoxyethanol, potassium sorbate, methylchloroisothiazolinone, methylisothiazolinone, fragrance

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

PURPOSE

ACNE TREATMENT

Section 55106-9 (55106-9)

ACTIVE INGREDIENT

SALICYLIC ACID 2%

Section 60561-8 (60561-8)

Other Information

Store at 15-30°C (59-86°F)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)