FDA.reportPublic FDA data

Clearasil Ultra

Manufacturer
RB Health (US) LLC
Effective date
2023-07-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:26:40

Label at a glance#

ProductClearasil Ultra Acne Clearing Scrub
Active ingredientSALICYLIC ACID
Label structure12 sections

Dosage and administration

Wet face Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area. Rinse thoroughly with warm water and pat dry. For best results, use twice daily.

Storage and handling

keep tightly closed store in a cool dry place.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes. If product gets into the eyes rinse thoroughly with water.
  • with other topical acne medications, at the same time or immediately following use of this product, increased dryness or irritation of the skin may occur. If this occurs, only one acne medication should be used unless directed by a doctor.
  • limit use to the face and neck.

OTC - STOP USE SECTION

Stop use and ask doctor ifskin or eye irritation develops

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.In case of accidental ingestion, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Wet face
  • Dispense product into hands and massage gently onto face and neck, avoiding the delicate eye area.
  • Rinse thoroughly with warm water and pat dry.
  • For best results, use twice daily.

Other information

STORAGE AND HANDLING SECTION

  • keep tightly closed
  • store in a cool dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Polyethylene, PPG-15 Stearyl Ether, Glycerin, Stearyl Alcohol, Cetyl Betaine, Distearyldimonium Chloride, Sodium Lauryl Sulfate, Cetyl Alcohol, Alcohol, Steareth-21, Sodium Chloride, Behenyl Alcohol, Synthetic Wax, Steareth-2, Fragrance, Xanthan Gum, Lavandula Stoechas Extract, Helichrysum Italicum Extract, Cistus Monspeliensis Extract, Lauryl Alcohol, Mica, Disodium EDTA, PEG-40 Hydrogenated Castor Oil, BHT, Magnesium Nitrate, Phenoxyethanol, Methylparaben, Methylchloroisothiazolinone, Magnesium Chloride, Butylparaben, Ethylparaben, Isobutylparaben, Propylparaben, Methylisothiazolinone, Ferric Ferrocyanide, Titanium Dioxide, Blue1.

Questions? Comments?

OTC - QUESTIONS SECTION

Call 1-866-25-CLEAR
(1-866-252-5327)*

SPL UNCLASSIFIED SECTION

Distributed by: Reckitt Benckiser Inc.
Parsippany, NJ 07054-0224
Made in USA © RBI 2009

0223412

PRINCIPAL DISPLAY PANEL - 150 mL Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dermatologist
Tested

Clearasil
Ultra ®

NEW
FORMULA

Acne Clearing
Scrub

100%

Fights 100% of acne

2% SALICYLIC ACID ACNE MEDICATION
5 FL. OZ. (150 mL)

Principal Display Panel
Principal Display Panel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63824-318-012023-08-31C16284748780-1ba0f9c33-2feb-a910-e053-dadaa90a0b85Clearasil Ultra ®
63824-318-012021-01-29C16284748780-1ba0f9c33-2feb-a910-e053-dadaa90a0b85Clearasil Ultra ®

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Salicylic AcidACTIVE INGREDIENTO414PZ4LPZ1
Salicylic AcidACTIVE MOIETYO414PZ4LPZ1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63824-31863824-318-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
PPG-15 STEARYL ETHER1II18XLS1LIACT
GLYCERINPDC6A3C0OXIACT
STEARYL ALCOHOL2KR89I4H1YIACT
CETYL BETAINEE945X08YA9IACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CETYL ALCOHOL936JST6JCNIACT
ALCOHOL3K9958V90MIACT
STEARETH-2153J3F32P58IACT
SODIUM CHLORIDE451W47IQ8XIACT
DOCOSANOL9G1OE216XYIACT
STEARETH-2V56DFE46J5IACT
XANTHAN GUMTTV12P4NEEIACT
LAURYL ALCOHOL178A96NLP2IACT
MICAV8A1AW0880IACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
MAGNESIUM NITRATE77CBG3UN78IACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
MAGNESIUM CHLORIDE02F3473H9OIACT
BUTYLPARABEN3QPI1U3FV8IACT
ETHYLPARABEN14255EXE39IACT
ISOBUTYLPARABEN0QQJ25X58GIACT
PROPYLPARABENZ8IX2SC1OHIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
FERRIC FERROCYANIDETLE294X33AIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
00de6498-6753-765a-e063-6394a90aea20d8baf9e5-1bea-4d1e-858c-e490db895f5d2023-07-19WarningsExact identifier
spl id: 00de6498-6753-765a-e063-6394a90aea20
spl set id: d8baf9e5-1bea-4d1e-858c-e490db895f5d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.