FDA.reportPublic FDA data

ProcureVITAMIN A AND D

Manufacturer
TWIN MED, LLC
Effective date
2022-01-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 22:19:31

Label at a glance#

ProductProcureVITAMIN A AND D VITAMIN A AND D
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........75% 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 15 0 - 30 0 c ( 59 0 - 86 0 F)
  • Avoid excessive heat and humidity
  • Tamper Evident
  • Do not use if packet it torn, cut or opened.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Liquid Paraffin, Vitamin A, and Vitamin D

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Procure
VITAMIN A AND D
OINTMENT
Skin Protectant
12
tubes
Each Tube
Net Weight: 4 ounces
Procure
VITAMIN A AND D
OINTMENT
Skin Protectant
144
PACKETS
Net Weight: 5 grams Untitled.jpgUntitled.jpg Untitledd.jpgUntitledd.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55681-212-022022-01-03C16284748780-19d75b9d0-5bed-f424-e053-dadaa90a57ceDrug Facts
55681-212-022020-01-31C16284748780-19d75b9d0-5bed-f424-e053-dadaa90a57ceDrug Facts

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U1
PETROLATUMACTIVE MOIETY4T6H12BN9U1
LANOLININACTIVE INGREDIENT7EV65EAW6H1
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
VITAMIN AINACTIVE INGREDIENT81G40H8B0T1
VITAMIN DINACTIVE INGREDIENT9VU1KI44GP1

Products#

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

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55681-21255681-212-02

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
LANOLIN7EV65EAW6HIACT
LIGHT MINERAL OILN6K5787QVPIACT
VITAMIN A81G40H8B0TIACT
VITAMIN D9VU1KI44GPIACT
PETROLATUM4T6H12BN9UACTIB

Source Document#

Source XML

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 · 28 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL162 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM, AUGMENTED / TOPICAL25 %w/wExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 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
efe1446f-e0b5-2613-e053-2995a90a575b1e484d47-18c5-4567-bac2-d1ab7231ec6b2022-12-15WarningsExact identifier
spl set id: 1e484d47-18c5-4567-bac2-d1ab7231ec6b

Reported adverse events (FAERS/openFDA)#

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