Label: GALENTIC VITAMIN A D- petrolatum ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

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.

Drug Label Information

Updated August 8, 2013

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredient                               Purpose

    White Petrolatum USP (76%)            Skin Protectant

  • Purpose:

    • Helps treat and prevent diaper rash
    • Helps seal out wetness
    • Temporarily protects minor * cuts * scrapes * burns
    • Temporarily helps protect and help relieve chapped and cracked skin and 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:

    For External Use Only

  • When using this product:

    • Do not get in eyes
  • Stop use and ask a doctor if:

    • If condition worsens
    • symptoms last more than 7 days or clear up and occur again in a few days
  • Do not use:

    Do not use:

    • Deep or puncture wounds
    • animal bites
    • serious burns
  • Keep out of reach of children

    Keep out of reach of children

    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions for diaper rash:

    • Change wet and soiled diapers promptly
    • Cleanse the diaper area and allow to dry
    • Apply as needed
  • Other information:

    • Store at room temperature 15 deg C to 30 deg C    59 deg F to 86 deg F
    • Avoid excessive heat
  • Inactive Ingredients:

    Inactive Ingredients: Light Liquid Parafin, Vitamin A, Vitamin D

  • Principal Display Panel

    Galentic Vit AD.jpg

    Galentic Vit AD

  • INGREDIENTS AND APPEARANCE
    GALENTIC VITAMIN A D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50382-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM.76 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    LANOLIN (UNII: 7EV65EAW6H)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50382-003-01113.4 g in 1 TUBE
    2NDC:50382-003-02425.25 g in 1 JAR
    3NDC:50382-003-0328.35 g in 1 TUBE
    4NDC:50382-003-0456.7 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34708/06/2013
    Labeler - Galentic Pharma (India) Priva Te Limited (918531450)
    Establishment
    NameAddressID/FEIBusiness Operations
    Galentic Pharma (India) Priva Te Limited918531450manufacture(50382-003)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!