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Drug Facts

Manufacturer
TWIN MED, LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-08-06 06:10:15

Label at a glance#

Productprocure
Active ingredientPETROLATUM
Label structure7 sections

Indications and uses

Helps treat and prevent diaper rash Helps seal out wetness Temporarily protects minor cuts, scrapes and burns Temporarily helps protect and helps relieve chapped and cracked skin or lips Helps prevent and protect from the drying effects of wind and cold weather Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when expos...

Dosage and administration

Change wet and soiled diapers promptly Cleanse the diaper area and allow to dry Apply as needed

Label contents#

Full prescribing information#

Active Ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum, USP, 100% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • Helps treat and prevent diaper rash
  • Helps seal out wetness
  • Temporarily protects minor cuts, scrapes and burns
  • Temporarily helps protect and helps relieve chapped and cracked skin or lips
  • Helps prevent and protect from the drying effects of wind and cold weather
  • Helps prevent and protect from chafed skin or mionr skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Directions

DOSAGE & ADMINISTRATION SECTION

  • Change wet and soiled diapers promptly
  • Cleanse the diaper area and allow to dry
  • Apply as needed

Warnings

WARNINGS SECTION

For External Use Only.

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • The condition persists or gets worse
  • Symptoms persists for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

OTHER SAFETY INFORMATION

  • Store at controlled room temperature 15 o- 30 oC(59 o--86 oF)
  • Avoid excessive heat and humidity
  • Tamper evident
  • Do not use if packet is torn, cut or opened

When using this product

OTC - WHEN USING SECTION

  • Do not get into eyes

Inactive Ingredients

INACTIVE INGREDIENT SECTION

None

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact PanelProCure

PETROLATUM

JELLY

Skin Protectant

144

PACKETS

Net Weight: 5 grams

Item No. PCPJO5 Untitled.jpgUntitled.jpg

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816516010033GTIN-13: 0816516010033
EAN-13: 0816516010033
GTIN-12: 816516010033
UPC-A: 816516010033
GTIN storage (14 digits): 00816516010033		Untitled.jpg
BarcodeEAN-130816516015793GTIN-13: 0816516015793
EAN-13: 0816516015793
GTIN-12: 816516015793
UPC-A: 816516015793
GTIN storage (14 digits): 00816516015793		Petroleum Jelly 2oz tube - Procure.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55681-211-012022-01-20C16284748780-19d75b9d0-887e-f424-e053-dadaa90a57ceDrug Facts
55681-211-012022-01-20C16284748780-19d75b9d0-887e-f424-e053-dadaa90a57ceDrug Facts
55681-211-012020-01-31C16284748780-19d75b9d0-887e-f424-e053-dadaa90a57ceDrug Facts
55681-211-012020-01-31C16284748780-19d75b9d0-887e-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-21155681-211-01, 55681-211-02, 55681-211-03

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-01-08full-release2026-06-01 00:06:51

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
procurePETROLATUMTWIN MED, LLC32520d8f-91ee-47a1-9129-bf0746791f4b2026-08-03WarningsExact identifier
ndc (package): 55681-211-01
ndc (package): 55681-211-03
ndc (package): 55681-211-02
ndc (product): 55681-211
ndc11 (package): 55681021103
ndc11 (package): 55681021102
ndc11 (package): 55681021101
spl id: 5828478c-279a-359b-e063-6294a90a78f5
spl set id: 32520d8f-91ee-47a1-9129-bf0746791f4b

Reported adverse events (FAERS/openFDA)#

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