FDA.reportPublic FDA data

Drug Facts

Manufacturer
TWIN MED, LLC
Effective date
2026-08-03
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
daily-update
Hydrated at
2026-08-06 06:10:32

Label at a glance#

ProductPROCURE VITAMIN A AND D Skin Protectant
Active ingredientPETROLATUM
Label structure8 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 chafed skin or minor skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure t...

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 Ingredients(in each gram)

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum (USP 93.4% 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 chafed skin or minor skin irritations associated with diaper rash, with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Warnings

WARNINGS SECTION

For External Use Only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with eyes

Stop use and ask doctor if

OTC - STOP USE SECTION

  • The condition persists or get worse
  • Symptoms last more than 7 days or clear up and occur again in a few days

Do not use on

OTC - DO NOT USE SECTION

  • Deep or puncture wounds
  • Animal bites
  • Serious burns

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

  • Store at room temperature 150 - 300 c ( 590 - 860 F)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet it torn, cut or opened.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CI 17240, Lanolin, Light Liquid Paraffin, Vitamin A, Vitamin D

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display and Drug Fact PanelPrincipal Display and Drug Fact Panel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816516012419GTIN-13: 0816516012419
EAN-13: 0816516012419
GTIN-12: 816516012419
UPC-A: 816516012419
GTIN storage (14 digits): 00816516012419		55681215.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55681-215-022021-09-22C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-022021-09-22C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-032021-09-22C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-032021-09-22C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-022020-01-31C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-022020-01-31C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-032020-01-31C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts
55681-215-032020-01-31C16284748780-19d75b9d0-e11f-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP2
VITAMIN AINACTIVE INGREDIENT81G40H8B0T2
VITAMIN DINACTIVE INGREDIENT9VU1KI44GP2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-21555681-215-03, 55681-215-02, 55681-215-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
SOLVENT YELLOW 18L4SQI4K87SIACT
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
92025-06-11full-release2026-06-01 01:03:38

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii+route+dosage form
4 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates

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
PROCURE VITAMIN A AND D Skin ProtectantPETROLATUMTWIN MED, LLCbbbca68e-1b65-49b1-a5fa-ed4da55d05e32026-08-03WarningsExact identifier
ndc (package): 55681-215-03
ndc (package): 55681-215-06
ndc (package): 55681-215-02
ndc (product): 55681-215
ndc11 (package): 55681021502
ndc11 (package): 55681021506
ndc11 (package): 55681021503
spl id: 58276185-b355-26ce-e063-6294a90a6e07
spl set id: bbbca68e-1b65-49b1-a5fa-ed4da55d05e3

Reported adverse events (FAERS/openFDA)#

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