Label: A AND D- petrolatum ointment

  • NDC Code(s): 61010-4405-1
  • Packager: Safetec of America, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated February 9, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active Ingredient

    White Petrolatum 76 %

  • Purpose

    Skin Protectant

  • Use

    • Temporarily protects minor:
      • cuts
      • scrapes
      • burns
    • Temporarily protects and helps relieve chafed, chapped, or cracked skin and lips
    • Helps prevent and protect from the drying effects or wind and cold weather
  • Warnings

    For external use only.

    Do not use on

    • deep or puncture wounds
    • animal bites
    • serious burns

    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

  • Other Information

    Store at room temperature

    • Avoid excessive heat
  • Inactive Ingredients

    Lanolin, Lavender Oil, Light Liquid Paraffin, Vitamin A, Vitamin D

  • Principal Display Panel –Tube Label

    Safetec®

    A&D Ointment

    Skin Protectant with Vitamins A & D

    Net Wt. 4oz. (113.4g)

    Reorder No. 56001

    Manufactured for: Safetec of America INC.

    Buffalo, NY 14215 | 1-800-456-7077

    Made in IndiaKD/739

    Principal Display Panel –Tube Label
  • INGREDIENTS AND APPEARANCE
    A AND D 
    petrolatum ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61010-4405
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    LANOLIN (UNII: 7EV65EAW6H)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    LIGHT MINERAL OIL (UNII: N6K5787QVP)  
    VITAMIN A ACETATE (UNII: 3LE3D9D6OY)  
    CHOLECALCIFEROL (UNII: 1C6V77QF41)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61010-4405-1113.4 g in 1 TUBE; Type 0: Not a Combination Product11/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01611/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262manufacture(61010-4405)
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