MARKET AMERICA (as PLD) - TIMELESS PRESCRIPTION - ACNE REPAIRING LOTION (76209-354) - DELIST

TIMELESS PRESCRIPTION - ACNE REPAIRING by

Drug Labeling and Warnings

TIMELESS PRESCRIPTION - ACNE REPAIRING by is a Otc medication manufactured, distributed, or labeled by Market America, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TIMELESS PRESCRIPTION - ACNE REPAIRING STEP 3- benzoyl peroxide lotion 
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 - ACNE REPAIRING LOTION (76209-354) - 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

• CLEANSE THE SKIN THOROUGHLY BEFORE APPLYING THIS PRODUCT
• COVER THE ENTIRE AFFECTED AREA WITH A THIN LAYER 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
• 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, CYCLOPENTASILOXANE, ACRYLATES COPOLYMER, BUTYLENE GLYCOL, GLYCERYL STEARATE, PEG-100 STEARATE, DIMETHICONE, CETEARYL ALCOHOL, POLYACRYLAMIDE, C13-14 ISOPARAFFIN, LAURETH-7, CETEARETH-20, ALLANTOIN, PANTHENOL, BISABOLOL, PEG-60 ALMOND GLYCERIDES, CAPRYLYL GLYCOL, GLYCERIN, CARBOMER, NORDIHYDROGUAIARETIC ACID, OLEANOLIC ACID, PHENOXYETHANOL, METHYLISOTHIAZOLINONE, SODIUM HYDROXIDE

TIMELESS PRESCRIPTION - ACNE REPAIRING  STEP 3
benzoyl peroxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76209-354
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	2.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
DIMETHICONE (UNII: 92RU3N3Y1O)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
LAURETH-7 (UNII: Z95S6G8201)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ALLANTOIN (UNII: 344S277G0Z)
PANTHENOL (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
GLYCERIN (UNII: PDC6A3C0OX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
NORDIHYDROGUAIARETIC ACID, (+/-)- (UNII: 7PZ73W4ZNR)
OLEANOLIC ACID (UNII: 6SMK8R7TGJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76209-354-23	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	02/01/2021	12/31/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M006	02/01/2021	12/31/2021

Labeler - Market America, Inc. (797412236)

Revised: 4/2023

Document Id: f8711755-ede5-713d-e053-6394a90a6303

34390-5

Set id: 0669146e-0faf-44bc-a982-36a6e82bc45a

Version: 4

Effective Time: 20230403