PREQUEL- multi purpose skin protectant ointment 
The Center Brands, LLC

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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DRUG FACTS

Purpose

Skin Protectant

Active Ingredients

Petrolatum 45.00%

Uses

•Temporarily protects and helps releive chafed, chapped or craked skin and lips

•Temporarily protects minor:

   •cuts

   •scrapes

   •burns

•Helps protect form the drying effects of wind and cold weather

Warnings

Fox external use only.

When using this product do not get into eyes

Stop use and ask a doctor if

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swalled, get medical help or contact a Poison Control Center right away.

Directions

Apply as needed.

Inactive Ingredients

Parrafinum Liquidum, Ozokerite, Dimethicone, Brassica Campestric/Aleuites Fordi Oil Copolymer, Bisabolol, Cetylhydroxyproline Palmitamide, Oryza Sativa Bran Extract, Helianthus Annuus Extract, Tocopherol, Rosmarinus Officinalis Leaf Extract, Stearic Acid, Brassica Campestris Sterols, 1,2-Hexanediol, Hexyldecanol

Other Information

Visit prequelskin.com

Principal Display Panel

82800-008

PREQUEL 
multi purpose skin protectant ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82800-008
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM45 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
HEXYLDECANOL (UNII: 151Z7P1317)  
CERESIN (UNII: Q1LS2UJO3A)  
RAPESEED STEROL (UNII: B46B6DD20U)  
ROSEMARY (UNII: IJ67X351P9)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUNFLOWER SEED (UNII: R9N3379M4Z)  
TOCOPHEROL (UNII: R0ZB2556P8)  
1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
BRASSICA RAPA SUBSP. OLEIFERA OIL (UNII: N4G8379626)  
LEVOMENOL (UNII: 24WE03BX2T)  
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)  
RICE BRAN (UNII: R60QEP13IC)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:82800-008-011 in 1 BOX07/13/2023
156.6 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalM01607/13/2023
Labeler - The Center Brands, LLC (076228814)

Revised: 9/2023
Document Id: 05de2a4c-65db-f02a-e063-6394a90ae73c
Set id: ffc45799-ec8d-6fd8-e053-6294a90aa38c
Version: 5
Effective Time: 20230921
 
The Center Brands, LLC