DAWNMIST HYPOALLERGENIC PETROLEUM (PETROLATUM) JELLY [DONOVAN INDUSTRIES, INC.]

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DAWNMIST HYPOALLERGENIC PETROLEUM (PETROLATUM) JELLY [DONOVAN INDUSTRIES, INC.]
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NDC 55504-0432-1, 55504-0432-2
Set ID 0f56b541-4482-4490-bde2-23524fb0d973
Category HUMAN OTC DRUG LABEL
Packager Donovan Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART347
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  • Active Ingredient

    White Petrolatum, USP 100%


  • Purpose

    Skin Protectant

  • Uses

    • Temporarily protects minor cuts, scraps or burns
    • Temporarily protects ad helps relieve chapped or cracked skin and lips.
    • Helps protect from the drying effects of wind and cold weather
  • Warnings:

    For external use only.

    Do not use on:

    • deep puncture wounds
    • lacerations or infections
    • serious burns
    • animal bites

    Stop use and ask doctor

    • if condition does not improve or lasts more than 7 days

    Keep out of reach of children.

    • If swallowed get medical help or contact Poison Control Center right away
    • If redness or swelling develops, consult a physician promptly
  • Directions

    Apply as often as necessary.

  • Inactive Ingredients

    none

  • SPL UNCLASSIFIED SECTION

    Manufactured for:
    Donovan Industries, Inc.
    Tampa, FL 33623-3061
    800.334.4404
    Made in China

  • PRINCIPAL DISPLAY PANEL

    Hypoallergenic

    Soothes and Moisturizes



    DawnMist

    Hypoallergenic Petroleum Jelly

  • Product Container Label

    Petroleum Jelly Label

  • Outer Container Label

    Petroleum Jelly Label

  • INGREDIENTS AND APPEARANCE
    DAWNMIST HYPOALLERGENIC PETROLEUM 
    petrolatum jelly
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-0432
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55504-0432-256 g in 1 TUBE
    2NDC:55504-0432-1144 in 1 BOX
    256 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34709/27/2011
    Labeler - Donovan Industries, Inc. (096662267)
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