DAWNMIST HYPOALLERGENIC 100 PERCENT PURE PETROLEUM- petrolatum jelly 
Dukal Corporation

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.

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DawnMist Hypoallergenic 100% Pure Petroleum Jelly

Active Ingredient

White Petrolatum, USP (100%)

Purpose

Skin Protectant

Uses

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

When using this product

  • Do not get into eyes

Warnings

For external use only.

Do not use on:

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

Stop use and ask a 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 needed

DawnMist Hypoallergenic 100% Pure Petroleum Jelly 2oz/56g (65517-1016-1)

PetroleumJelly


DAWNMIST HYPOALLERGENIC 100 PERCENT PURE PETROLEUM 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-1016
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM100 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ECHINACEA PURPUREA FLOWERING TOP WATER (UNII: G72P70SL42)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-1016-156 g in 1 TUBE; Type 0: Not a Combination Product05/02/201305/02/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34705/02/201305/02/2013
Labeler - Dukal Corporation (791014871)

Revised: 9/2018
Document Id: 75c09285-89b8-60bc-e053-2a91aa0aeb4a
Set id: 22fc4cfd-9a62-44ab-938c-6a11ba2bad18
Version: 2
Effective Time: 20180913
 
Dukal Corporation