TIMELESS PRESCRIPTION - RENEWING ACNE CLEANSER STEP 1- benzoyl peroxide cream 
Market America, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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MARKET AMERICA (as PLD) - Timeless Prescription Renewing Acne Cleanser (76209-353) - DELIST

ACTIVE INGREDIENT

BENZOYL PEROXIDE 2.5%

PURPOSE

ACNE TREATMENT

USES

  • FOR THE TREATMENT OF ACNE

WARNINGS

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

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

DIRECTIONS

  • 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

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

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

TIMELESS PRESCRIPTION - RENEWING ACNE CLEANSER  STEP 1
benzoyl peroxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76209-353
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE2.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM COCOYL ISETHIONATE (UNII: 518XTE8493)  
SYNTHETIC WAX (1200 MW) (UNII: Q3Z4BCH099)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
CETYL ESTERS WAX (UNII: D072FFP9GU)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
TRIDECYL STEARATE (UNII: A8OE252M6L)  
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)  
TRIDECYL TRIMELLITATE (UNII: FY36J270ES)  
HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
ZINC PIDOLATE (UNII: C32PQ86DH4)  
CINNAMON (UNII: 5S29HWU6QB)  
GINGER (UNII: C5529G5JPQ)  
SANGUISORBA OFFICINALIS ROOT (UNII: 4NYV2HT01X)  
BUTYL AVOCADATE (UNII: Q86RQ0D402)  
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
LAURETH-7 (UNII: Z95S6G8201)  
SORBITOL (UNII: 506T60A25R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76209-353-22118 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product02/01/202112/31/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM00602/01/202112/31/2021
Labeler - Market America, Inc. (797412236)

Revised: 4/2023
 
Market America, Inc.