Prequel by The Center Brands, LLC DRUG FACTS

Prequel by

Drug Labeling and Warnings

Prequel by is a Otc medication manufactured, distributed, or labeled by The Center Brands, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days. Do not use on deep or puncture woulds  animal bites  serious burns.

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

PREQUEL 
multi purpose skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82800-008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	45 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82800-008-01	1 in 1 BOX	07/13/2023
1		56.6 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	M016	07/13/2023

Labeler - The Center Brands, LLC (076228814)

Revised: 9/2023

Document Id: 05de2a4c-65db-f02a-e063-6394a90ae73c

34390-5

Set id: ffc45799-ec8d-6fd8-e053-6294a90aa38c

Version: 5

Effective Time: 20230921