Label: VITAMIN A AND D- skin protectant ointment

  • NDC Code(s): 53329-090-14, 53329-090-16, 53329-090-96
  • Packager: Medline Industries, LP
  • 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 June 16, 2023

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  • Active Ingredient (in each gram)

    Petrolatum 93.5%

  • Purpose

    Skin Protectant

  • Uses

    • temporarily protects and relieves
    • minor cuts
    • scrapes
    • burns
    • chapped or cracked skin and lips
  • Warnings

    • for external use only

    Stop use and consult a doctor if

    • condition worsens
    • if symptoms last for more than 7 days or clear up and occur again within a few days

    When using this product

    • avoid contact with eyes

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    KEEP OUT OF REACH OF CHILDREN.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply as needed.

  • Other information

    • store at controlled room temperature 68- 77 ºF (20-25 ºC)
    • Use only if packaging is intact.
  • Inactive ingredients

    corn oil, light mineral oil, vitamin A palmitate, vitamin D

  • Manufacturing Information

    Manufactured for:

    Medline Industries, LP

    Three Lakes Drive, Northfield, IL 60093 USA

    Manufactured in USA of foreign and domestic materials

    www.curad.com

    1-800-633-5463

    REF: CUR003501

    V1 RC22ULI

  • Package Label

    Label V1 RC22ULI

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    skin protectant ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53329-090
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM935 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    VITAMIN D (UNII: 9VU1KI44GP)  
    CORN OIL (UNII: 8470G57WFM)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53329-090-141 in 1 BOX01/01/201912/31/2024
    156.6 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53329-090-96144 in 1 CARTON01/01/201912/31/2024
    2NDC:53329-090-165 g in 1 PACKET; Type 0: Not a Combination Product
    3NDC:53329-090-165 g in 1 PACKET; Type 0: Not a Combination Product03/01/201012/31/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM01603/01/201012/31/2024
    Labeler - Medline Industries, LP (025460908)
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