DAWNMIST MOISTURE BARRIER- petrolatum jelly 
Dukal Corp

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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Drug Facts

Active Ingredients

Petrolatum 98.3%

Purpose

Skin Protectant

Use:

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

Warnings:

For external use only.

  • Do not use on: deep and 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 lasts 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 Poison Control Center right away.
  • If redness or swelling develops consult a physician promptly.

Directions:

Apply as often as necessary.

Inactive Ingredients:

Benzethonium Chloride, Tocopheryl Acetate (Vitamin E), Cholecalciferol (Vitamin D), Retinyl Palmitate (Vitamin A), Cococaprylate Caprate, Aloe Extract, Corn Oil

REF MB4502

DUKAL™
Corporation

Manufactured for: DUKAL Corporation
Ronkonkoma, NY 11779
(631) 656-3800 ♦ www.dukal.com
Made in USA
D06191401

Principal Display Panel - Tube Label

NDC 65517-2021-1

DawnMist®

INCONTINENCE

Moisture Barrier
Ointment

CONTAINS ALOE &
VITAMIN A, D, & E

PROTECTS SKIN FROM
EXCESS MOISTURE

2 OZ. (56 g)

Principal Display Panel - Tube Label
DAWNMIST MOISTURE BARRIER 
petrolatum jelly
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2021
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM98.3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZETHONIUM CHLORIDE (UNII: PH41D05744)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
RETINOL (UNII: G2SH0XKK91)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
ALOE (UNII: V5VD430YW9)  
CORN OIL (UNII: 8470G57WFM)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:65517-2021-156 g in 1 TUBE; Type 0: Not a Combination Product10/01/201410/01/2014
2NDC:65517-2021-25 g in 1 TUBE; Type 0: Not a Combination Product10/01/201410/01/2014
3NDC:65517-2021-3198 g in 1 TUBE; Type 0: Not a Combination Product10/01/201410/01/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/01/201410/01/2014
Labeler - Dukal Corp (791014871)
Establishment
NameAddressID/FEIBusiness Operations
Unipack Inc009248480manufacture(65517-2021)

Revised: 9/2018
Document Id: 75b29ea6-1090-3591-e053-2991aa0a3829
Set id: d8851d9b-f2a2-447e-9771-3f2d7e83ce71
Version: 2
Effective Time: 20180912
 
Dukal Corp