FDA.reportPublic FDA data

Vitamin A & Vitamin D Ointment

Manufacturer
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date
2012-09-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:45:59

Label at a glance#

ProductVitamin A and Vitamin D
Active ingredientPETROLATUM
Label structure14 sections

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

White Petrolatum (929.3 mg)

Purpose:

OTC - PURPOSE SECTION

Emollient

INDICATIONS & USAGE SECTION

Uses:

  • first aid in
  • minor burns
  • scalds
  • sunburn
  • windburn
  • diaper rash
  • chafing
  • chapped skin
  • nipple care
  • abrasions
  • cuts
  • ulcers

WARNINGS SECTION

Warnings:

For external use only.

Ask doctor before use if you have severe or extensive burns.

When using this product the treatment of ulcers, severe cuts or wounds should be under the direction of a doctor.

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.

DOSAGE & ADMINISTRATION SECTION

Directions:

  • cleanse affected area with mild soap and warm water
  • dry thoroughly
  • apply Vitamin A & Vitamin D ointment in a thin layer to the affected area directly to the skin or by spreading on sterile gauze or clean cloth
  • bandage loosely

SPL UNCLASSIFIED SECTION

Other information:

  • do not use if seal is punctured or is not visible. To open, reverse cap to puncture seal
  • store at room temperature
  • see crimp of tube for Lot Number and Exp. Date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

fragrance, lanolin, paraffin, vitamin A (as palmitate), vitamin D

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0035-01

Fougera®

Vitamin A & Vitamin D Ointment

(Emollient)

NET WT 56.70 g (2 Oz)

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0035-01

Vitamin A & Vitamin D Ointment (Emollient)

To promote healing of minor skin irritaions

NET WT 2 Oz (56.70 g)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0035-45

Vitamin A & Vitamin D Ointment

(Emollient)

This product available in tubes at pharmacy

NET WT 5 g (approx. 5/32 Oz)

E. FOUGERA & CO.
A division of Fougera Pharamceuticals Inc., Melville, NY 11747

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0035-45

Fougera®

Vitamin A & Vitamin D
Ointment

(Emollient)

This product available in tubes at pharmacy

1 GROSS
5 g (approx. 5/32 Oz) FOILPACS®

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera®

NDC 0168-0035-16

Vitamin A & Vitamin D
Ointment (Emollient)

NET WT 453.6 g (1 lb)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0168-0035-012024-08-22C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-022024-08-22C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-042024-08-22C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-162024-08-22C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-452024-08-22C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-012020-01-31C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-022020-01-31C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-042020-01-31C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-162020-01-31C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment
0168-0035-452020-01-31C16284748780-19d75b9d0-8530-f424-e053-dadaa90a57ceVitamin A & Vitamin D Ointment

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0168-0035-01GM - Gram0168-00357bbb4226-b1cb-489f-b9b2-6ebb84b36e4e12013-02-13
0168-0035-04GM - Gram0168-00353d1e8cf5-34ec-4f18-864c-c7daeb5273de12013-02-13
0168-0035-16GM - Gram0168-0035befb0940-7f94-40fc-9914-2542f671804d12013-02-13
0168-0035-45GM - Gram0168-0035fa4e014a-ae91-44bf-a9a5-30e4e34a496a12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE2
VITAMIN A PALMITATEINACTIVE INGREDIENT1D1K0N0VVC2
VITAMIN DINACTIVE INGREDIENT9VU1KI44GP2

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
0168-00350168-0035-01, 0168-0035-02, 0168-0035-04, 0168-0035-45, 0168-0035-16

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
PETROLATUM4T6H12BN9UACTIB
LANOLIN7EV65EAW6HIACT
PARAFFINI9O0E3H2ZEIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
VITAMIN D9VU1KI44GPIACT

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 · 20 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSPRAY / NASALNAExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / TOPICAL10 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / VAGINAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / OPHTHALMIC3 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HOINTMENT / RECTAL105 mgExact identifier — unii candidate
9 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
4af8584f-f458-4947-9840-e0fdcbf0a13cb43b9b0d-66d0-4011-b44a-f1fe4adf1ec12021-09-22WarningsExact identifier
spl set id: b43b9b0d-66d0-4011-b44a-f1fe4adf1ec1

Reported adverse events (FAERS/openFDA)#

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