Label: VITAMIN A AND D- petrolatum ointment

  • NDC Code(s): 57896-112-05, 57896-112-14
  • Packager: GERI-CARE PHARMACEUTICAL CORP
  • 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 May 25, 2020

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

  • ACTIVE INGREDIENT

    Active ingredient (in each gram)

    White Petrolatum 93.5%

  • PURPOSE

    Purpose

    Skin Protectant

  • INDICATIONS & USAGE

    Uses

    • temporarily relieves minor cuts, scrapes, burns
    • temporarily protects and helps relieve chapped or cracked skin and lips
    • helps protect from the effects of wind and cold weather
  • WARNINGS

    Warnings For external use only.

  • DO NOT USE

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    In case of deep punctured wounds or severe burns, consult a physican.

  • STOP USE

    Stop use and ask a doctor if

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

  • DOSAGE & ADMINISTRATION

    Directions

    Apply as needed.

  • OTHER SAFETY INFORMATION

    Other information

    • Store at room temperature15-30ºC (59-86ºF).
    • Avoid excessive heat and humidity.
    • Tamper Evident. Do not use if packet is torn, cut or opened.
  • INACTIVE INGREDIENT

    Inactive ingredients Corn Oil, Light Mineral Oil, Vitamin A, Vitamin D

  • QUESTIONS

    Questions? Call 1-800-540-3765

  • PRINCIPAL DISPLAY PANEL

    11

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57896-112
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM93.5 g  in 100 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:57896-112-14144 in 1 CARTON05/01/2020
    1NDC:57896-112-055 g in 1 PACKET; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34705/01/2020
    Labeler - GERI-CARE PHARMACEUTICAL CORP (611196254)
    Registrant - GERI-CARE PHARMACEUTICAL CORP (611196254)