Label: VITAMIN A AND 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 December 29, 2009

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  • ACTIVE INGREDIENT

    Petrolatum, 94.8% w/w

  • PURPOSE

    skin protectant

  • USES

    • temporarily protects minor cuts, scrapes and burns
    • temporarily protects and helps relieve chapped or cracked skin
  • WARNINGS

    For external use only.

    Do not use on

    • deep or puncture wounds
    • serious burns
    • animal bites



    When using this product

    do not get into eyes

    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

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

  • DIRECTIONS

    Apply as needed.
  • SPL UNCLASSIFIED SECTION


  • OTHER INFORMATION

    Store at room temperature: 15°- 30° C (59° - 86° F)
  • INACTIVE INGREDIENTS


    cod liver oil (contains Vitamin A and Vitamin D), fragrance, lanolin, propylparaben
  • QUESTIONS


  • PACKAGE INFORMATION

    TRIAD

    Cat. No. 10-8717
    NDC 50730-8717-1

    Skin Protectant

    VITAMIN A AND D
    OINTMENT

    Use to temporarily protect chapped or cracked skin

    Contents:
    2 fl. oz. (59ml)

    Triad Group, Inc.
    700 West North Shore Drive
    Hartland, WI 53029
    MADE IN USA
    tube

  • INGREDIENTS AND APPEARANCE
    VITAMIN A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50730-8717
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Petrolatum (UNII: 4T6H12BN9U) (Petrolatum - UNII:4T6H12BN9U) Petrolatum0.948 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    cod liver oil (UNII: BBL281NWFG)  
    lanolin (UNII: 7EV65EAW6H)  
    propylparaben (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50730-8717-159 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34703/06/2004
    Labeler - H and P Industries, Inc. dba Triad Group (050259597)
    Registrant - H and P Industries, Inc. dba Triad Group (050259597)
    Establishment
    NameAddressID/FEIBusiness Operations
    H and P Industries, Inc. dba Triad Group050259597manufacture
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