FDA.reportPublic FDA data

TIMELESS PRESCRIPTION - RENEWING ACNE CLEANSER

Manufacturer
Market America, Inc.
Effective date
2021-02-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:54:06

Label at a glance#

ProductTIMELESS PRESCRIPTION - RENEWING ACNE CLEANSER STEP 1
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

FOR THE TREATMENT OF ACNE

Dosage and administration

APPLY CLEANSER TO WET SKIN AND GENTLY MASSAGE IN A CIRCULAR MOTION COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER AND RINSE THOROUGHLY WITH WARM WATER ONE TO THREE TIMES DAILY BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO TO THREE TIMES DAILY IF NEEDED OR AS DIRECTED BY A DOCTOR. IF BOTHERSOME DRYNESS OR PEELING OCCURS, REDUCE APPLICATION TO ONCE...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 2.5%

PURPOSE

OTC - PURPOSE SECTION

ACNE TREATMENT

USES

INDICATIONS & USAGE SECTION

  • FOR THE TREATMENT OF ACNE

WARNINGS

WARNINGS SECTION

FOR EXTERNAL USE ONLY.

WHEN USING THIS PRODUCT

  • AVOID UNNECESSARY SUN EXPOSURE AND USE A SUNSCREEN
  • AVOID CONTACT WITH THE EYES, LIPS AND MOUTH
  • AVOID CONTACT WITH HAIR AND DYED FABRICS, WHICH MAY BE BLEACHED BY THIS PRODUCT
  • SKIN IRRITATION MAY OCCUR, CHARACTERIZED BY REDNESS, BURNING, ITCHING, PEELING OR POSSIBLY SWELLING. IRRITATION MAY BE REDUCED BY USING THE PRODUCT LESS FREQUENTLY OR IN A LOWER CONCENTRATION.
  • SKIN IRRITATION AND DRYNESS IS MORE LIKELY TO OCCUR IF YOU USE ANOTHER TOPICAL ACNE MEDICATION AT THE SAME TIME. IF IRRITATION OCCURS, ONLY USE ONE TOPICAL ACNE MEDICATION AT A TIME.

DO NOT USE IF YOU

  • HAVE VERY SENSITIVE SKIN
  • ARE SENSITIVE TO BENZOYL PEROXIDE

STOP USE AND ASK A DOCTOR IF

  • IRRITATION BECOMES SEVERE

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • APPLY CLEANSER TO WET SKIN AND GENTLY MASSAGE IN A CIRCULAR MOTION
  • COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER AND RINSE THOROUGHLY WITH WARM WATER ONE TO THREE TIMES DAILY
  • BECAUSE EXCESSIVE DRYING OF THE SKIN MAY OCCUR, START WITH ONE APPLICATION DAILY, THEN GRADUALLY INCREASE TO TWO TO THREE TIMES 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
  • FOLLOW WITH STEP 2 OF THE SYSTEM
  • IF GOING OUTSIDE, APPLY SUNSCREEN AFTER USING THIS PRODUCT. IF IRRITATION OR SENSITIVITY DEVELOPS, STOP USE OF ALL PRODUCTS AND ASK A DOCTOR.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

WATER, SODIUM COCOYL ISETHIONATE, SYNTHETIC WAX, CETEARYL ALCOHOL, CETEARETH-20, ACRYLATES COPOLYMER, CETYL ESTERS, BUTYLENE GLYCOL, PHENOXYETHANOL, TRIDECYL STEARATE, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, TRIDECYL TRIMELLITATE, SODIUM HYALURONATE, ZINC PCA, CINNAMOMUM CASSIA BARK EXTRACT, ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, SANGUISORBA OFFICINALIS ROOT EXTRACT, BUTYL AVOCADATE, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, SORBITOL, SODIUM HYDROXIDE, SODIUM BENZOATE, POTASSIUM SORBATE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Timeless Prescription US 47757 Proof 8-11-17-signedTimeless Prescription US 47757 Proof 8-11-17-signed

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76209-353-222023-04-03C16284748780-1f386c649-fb30-0266-e053-dadaa90a7c1aTimeless Prescription Renewing Acne Cleanser
76209-353-222023-01-30C16284748780-1f386c649-fb30-0266-e053-dadaa90a7c1aTimeless Prescription Renewing Acne Cleanser

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76209-35376209-353-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZOYL PEROXIDEW9WZN9A0GMACTIB
WATER059QF0KO0RIACT
SODIUM COCOYL ISETHIONATE518XTE8493IACT
SYNTHETIC WAX (1200 MW)Q3Z4BCH099IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYOXYL 20 CETOSTEARYL ETHERYRC528SWUYIACT
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW)JZ1374NL9EIACT
CETYL ESTERS WAXD072FFP9GUIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
TRIDECYL STEARATEA8OE252M6LIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ZINC PIDOLATEC32PQ86DH4IACT
CINNAMON5S29HWU6QBIACT
GINGERC5529G5JPQIACT
SANGUISORBA OFFICINALIS ROOT4NYV2HT01XIACT
BUTYL AVOCADATEQ86RQ0D402IACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
LAURETH-7Z95S6G8201IACT
SORBITOL506T60A25RIACT
SODIUM HYDROXIDE55X04QC32IIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
f870f419-16ea-7ca9-e053-6294a90a9182a5b1cc51-cd9e-4ddf-afbc-762d98f302922023-04-03WarningsExact identifier
spl set id: a5b1cc51-cd9e-4ddf-afbc-762d98f30292

Reported adverse events (FAERS/openFDA)#

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