VITAMIN A AND D- vitamin a and d ointment 
GERITREX LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vitamin A&D Ointment

Drug Facts

Active Ingredient

White Petrolatum 95%

Purpose

A Skin protectant

Uses

For the temporary protection of minor cuts, scrapes, burns. Protects chafed skin

Warnings

FOR EXTERNAL USE ONLY.

When using this product: Avoid contact with eyes.

DO NOT apply over deep or punctured wounds, infections or lacerations

IF CONDITION WORSENS OR DOES NOT
IMPROVE WITHIN 7 DAYS STOP USE AND
CONSULT A PHYSICIAN.

KEEP OUT OF REACH OF CHILDREN.

In the event of accidental ingestion contact a Poison Control Center right away.

Directions

Cleanse area with mild soap and water. Apply liberally as often as necessary.

Storage

Inactive ingredients

Cod Liver Oil, Lanolin, Mineral Oil, Paraffin Wax, Phenoxyethanol, Vitamin A and Vitamin D

Label

113g Label

56g Label

5g Label

VITAMIN A AND D 
vitamin a and d ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54162-000
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM30.8 g  in 56 g
Inactive Ingredients
Ingredient NameStrength
COD LIVER OIL (UNII: BBL281NWFG)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54162-000-04113 g in 1 TUBE; Type 0: Not a Combination Product01/01/2019
2NDC:54162-000-0256 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
3NDC:54162-000-055 g in 1 POUCH; Type 0: Not a Combination Product01/01/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/01/2018
Labeler - GERITREX LLC (112796248)
Establishment
NameAddressID/FEIBusiness Operations
GERITREX LLC112796248manufacture(54162-000)

Revised: 10/2018
Document Id: 56da9d6a-984a-4d2b-8a1c-d23bfa573dcc
Set id: e6f217fc-d753-49f9-a467-b8bc7f7e7885
Version: 11
Effective Time: 20181012
 
GERITREX LLC