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
  • 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 November 1, 2019

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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 India KD/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 finalpart34711/01/2019
    Labeler - Safetec of America, Inc. (874965262)
    Registrant - Safetec of America, Inc. (874965262)
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