Label: DAWNMIST HYPOALLERGENIC PETROLEUM- petrolatum jelly

  • 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 September 27, 2011

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

View All Sections
  • 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!