FDA.reportPublic FDA data

Prequel

Manufacturer
The Center Brands, LLC
Effective date
2023-09-21
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:25:53

Label at a glance#

ProductPrequel
Active ingredientPETROLATUM
Label structure9 sections

Indications and 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

Dosage and administration

Apply as needed.

Label contents#

Full prescribing information#

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Petrolatum 45.00%

Uses

INDICATIONS & USAGE SECTION

•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

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Apply as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

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

SPL UNCLASSIFIED SECTION

Visit prequelskin.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

82800-00882800-008

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82800-00882800-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
DIMETHICONE92RU3N3Y1OIACT
HEXYLDECANOL151Z7P1317IACT
CERESINQ1LS2UJO3AIACT
RAPESEED STEROLB46B6DD20UIACT
ROSEMARYIJ67X351P9IACT
STEARIC ACID4ELV7Z65APIACT
SUNFLOWER SEEDR9N3379M4ZIACT
TOCOPHEROLR0ZB2556P8IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
BRASSICA RAPA SUBSP. OLEIFERA OILN4G8379626IACT
LEVOMENOL24WE03BX2TIACT
CETYLHYDROXYPROLINE PALMITAMIDE74ONU0S62GIACT
RICE BRANR60QEP13ICIACT
PETROLATUM4T6H12BN9UACTIB

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
05de2a4c-65db-f02a-e063-6394a90ae73cffc45799-ec8d-6fd8-e053-6294a90aa38c2023-09-21WarningsExact identifier
spl id: 05de2a4c-65db-f02a-e063-6394a90ae73c
spl set id: ffc45799-ec8d-6fd8-e053-6294a90aa38c

Reported adverse events (FAERS/openFDA)#

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