FDA.reportPublic FDA data

Major ® Vitamin A&D Ointment Skin Protectant

Manufacturer
Major Pharmaceuticals | Garcoa, Inc.
Effective date
2012-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:45:51

Label at a glance#

ProductMajor Vitamin A and D Skin Protectant
Active ingredientPetrolatum, Lanolin
Label structure10 sections

Indications and uses

helps treat and prevent diaper rash protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips provides temporary protection of minor cuts, scrapes, burns and sunburn

Dosage and administration

apply liberally as often as necessary change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Storage and handling

store between 15° and 25°C (59° and 77°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Petrolatum 53.4%Skin Protectant
Lanolin 15.5%Skin Protectant

Uses

INDICATIONS & USAGE SECTION

  • helps treat and prevent diaper rash
  • protects chafed skin or minor skin irritation associated with diaper rash and helps seal out wetness
  • helps prevent and temporarily protects chafed, chapped, cracked or wind burned skin and lips
  • provides temporary protection of minor cuts, scrapes, burns and sunburn

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

For external use only

Do not use over deep or puncture wounds, infections, or lacerations

OTC - WHEN USING SECTION

When using this product avoid contact with the eyes

OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or does not improve within 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply liberally as often as necessary
  • change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
  • use with each diaper change, especially at bedtime when exposure to wet diapers may be prolonged

Other information

STORAGE AND HANDLING SECTION

  • store between 15° and 25°C (59° and 77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

cod liver oil (contains vitamin A & vitamin D), fragrance, light mineral oil, microcrystalline wax, paraffin

Questions?

OTC - QUESTIONS SECTION

adverse drug event call: 800-616-2471

SPL UNCLASSIFIED SECTION

Distributed By: Major Pharmaceuticals
31778 Enterprise Drive, Livonia, MI 48150, USA

PRINCIPAL DISPLAY PANEL - 454g Jar Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 00904-5843-27

MAJOR®

Compare to the
active ingredients in
A+D® Original
Ointment*

Vitamin
A & D Ointment

DIAPER RASH & ALL PURPOSE SKIN PROTECTANT

  • Treats & Prevents Diaper Rash
  • Helps Heal Dry, Chafed Skin
  • Protects & Soothes Minor Cuts & Burns

NET WT
1 LB (454g)

PRINCIPAL DISPLAY PANEL - 454g Jar Label
PRINCIPAL DISPLAY PANEL - 454g Jar Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-5843-27GM - Gram0904-584323f489c1-5348-48c6-bce4-de88554842d012013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
LanolinACTIVE INGREDIENT7EV65EAW6H1
PetrolatumACTIVE INGREDIENT4T6H12BN9U1
LanolinACTIVE MOIETY7EV65EAW6H1
PetrolatumACTIVE MOIETY4T6H12BN9U1
Cod Liver OilINACTIVE INGREDIENTBBL281NWFG1
Light Mineral OilINACTIVE INGREDIENTN6K5787QVP1
Microcrystalline WaxINACTIVE INGREDIENTXOF597Q3KY1
ParaffinINACTIVE INGREDIENTI9O0E3H2ZE1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-58430904-5843-27

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
Lanolin7EV65EAW6HACTIB
Cod Liver OilBBL281NWFGIACT
Light Mineral OilN6K5787QVPIACT
Microcrystalline WaxXOF597Q3KYIACT
ParaffinI9O0E3H2ZEIACT

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 · 34 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Light Mineral OilLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOIL / TOPICAL2509 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYOINTMENT / TOPICAL3575 mgExact identifier — unii candidate
4 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYCAPSULE, EXTENDED RELEASE / ORAL6 mgExact identifier — unii candidate
4 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPSYSTEM / TRANSDERMAL170 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPCREAM / TOPICAL456 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPFILM, EXTENDED RELEASE / TRANSDERMAL162 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, COATED / ORAL4.8 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYGEL / TOPICALNAExact identifier — unii candidate
4 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPTABLET, FILM COATED / ORAL2.49 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
Microcrystalline WaxMICROCRYSTALLINE WAXXOF597Q3KYCREAM / VAGINAL23 mgExact identifier — unii candidate
4 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPEMULSION / TOPICAL68100 mgExact identifier — unii candidate
19 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPGEL / TOPICAL20 mgExact identifier — unii candidate
19 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
ParaffinPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
Light Mineral OilLIGHT MINERAL OILN6K5787QVPPASTILLE / ORAL3.6 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

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
1874b9fb-ea3f-4444-a4b7-b20366a2a97ad7bf90ec-efa5-4345-966f-fe391c1eefff2012-08-30WarningsExact identifier
spl id: 1874b9fb-ea3f-4444-a4b7-b20366a2a97a
spl set id: d7bf90ec-efa5-4345-966f-fe391c1eefff

Reported adverse events (FAERS/openFDA)#

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