FDA.reportPublic FDA data

ProCure Vitamin A and D

Manufacturer
Twin Med LLC
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:18:45

Label at a glance#

ProductProCure Vitamin A and D
Active ingredientWHITE PETROLATUM
Label structure7 sections

Indications and uses

Uses Temporarily protects minor: cuts, scrapes and burns Temporarily protects chafed, chapped or cracked skin Helps protect against the drying effects of wind and cold weather Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness

Dosage and administration

Directions As a skin protectant: apply as needed For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum USP, 93.4% w/w

Purpose

OTC - PURPOSE SECTION

Skin Protectant

Uses

INDICATIONS & USAGE SECTION

Uses

  • Temporarily protects minor: cuts, scrapes and burns
  • Temporarily protects chafed, chapped or cracked skin
  • Helps protect against the drying effects of wind and cold weather
  • Helps treat and prevent diaper rash. Protects chafed skin due to diaper rash and helps seal out wetness

Warnings

WARNINGS SECTION

Warnings

For external use only

When using this product

OTC - STOP USE SECTION

When using this product do not get into the eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

OTC - DO NOT USE SECTION

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion contact a physician or Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions

  • As a skin protectant: apply as needed
  • For diaper rash: Change wet and soiled diaper promptly, cleanse the diaper area, and allow to dry. Apply ointment liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Lavender Oil, Light Mineral Oil, Vitamin A, Vitamin D

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vitamin AD ImageVitamin AD Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2601369petrolatum 93.4 % Topical OintmentPSN1
2601369petrolatum 0.934 MG/MG Topical OintmentSCD1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130816516017858GTIN-13: 0816516017858
EAN-13: 0816516017858
GTIN-12: 816516017858
UPC-A: 816516017858
GTIN storage (14 digits): 00816516017858		Vitamin AD Image.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55681-048-04ProCure Vitamin A and D113 g in 1 TUBEOINTMENT1131
55681-048-05ProCure Vitamin A and D5 g in 1 PACKETOINTMENT51
55681-048-14ProCure Vitamin A and D144 in 1 CONTAINEROINTMENT1441
55681-048-15ProCure Vitamin A and D425 g in 1 JAROINTMENT4251

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
55681-04855681-048-04, 55681-048-05, 55681-048-14, 55681-048-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
VITAMIN D9VU1KI44GPIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
LIGHT MINERAL OILN6K5787QVPIACT
LAVENDER OILZBP1YXW0H8IACT
WHITE PETROLATUMB6E5W8RQJ4ACTIB

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
ProCure Vitamin A and DWHITE PETROLATUM 93.4%Twin Med LLC3d385a07-2a12-fce7-e063-6294a90a32d62025-12-01WarningsExact identifier
ndc (package): 55681-048-14
ndc (package): 55681-048-05
ndc (package): 55681-048-04
ndc (package): 55681-048-15
ndc (product): 55681-048
ndc11 (package): 55681004804
ndc11 (package): 55681004814
ndc11 (package): 55681004815
ndc11 (package): 55681004805
spl id: 3d385a07-2a13-fce7-e063-6294a90a32d6
spl set id: 3d385a07-2a12-fce7-e063-6294a90a32d6

Reported adverse events (FAERS/openFDA)#

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