ADVANCED PETROLATUM- petrolatum ointment 
Ultra Seal 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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Drug Facts

Active Ingredients White Petrolatum 100%

Purpose: Skin Protectant

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


For external use only. Do not use in eyes, on puncture wounds, animal bites, or serious burns or for more than one week unless directed by a doctor..

Stop use and ask a doctor if condition worsens, persists, or recurs.



Keep out of reach of children

Directions: Apply as needed

Inactive Ingredients: None

image description

ADVANCED PETROLATUM 
petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42213-042
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM1 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42213-042-80144 in 1 BOX04/05/2011
1NDC:42213-042-055 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:42213-042-2828 g in 1 TUBE; Type 0: Not a Combination Product04/05/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/05/2011
Labeler - Ultra Seal Corporation (085752004)
Registrant - Ultra Seal Corporation (085752004)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation085752004pack(42213-042)
Establishment
NameAddressID/FEIBusiness Operations
Avatar Corporation103338687manufacture(42213-042)
Establishment
NameAddressID/FEIBusiness Operations
Ultra Seal Corporation944090448pack(42213-042)

Revised: 11/2018
Document Id: 667d78e7-62ee-4613-b1b4-08ab2e259a3c
Set id: f9164696-3128-4712-9276-e1d3e69dfd1b
Version: 2
Effective Time: 20181114
 
Ultra Seal Corporation