LINCOLN- white petrolatum ointment 
Lincoln Pharmaceuticals Ltd.

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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ACTIVE INGREDIENT

White Petrolatum USP (76% w/w)

PURPOSE

Skin Protectant

USES

WARNINGS:

FOR EXTERNAL USE ONLY

When using this product:

Stop Use and ask a doctor if

Do not use on

Keep out of reach of children

DIRECTIONS

For Diaper Rash:

change wet and soiled diaper promptly
cleanse the diaper area allow to dry
apply as needed

OTHER INFORMATION

INACTIVE INGREDIENTS

lanolin, lavender oil, light liquid paraffin, vitamin A, Vitamin D

Principal Display and Drug Fact Label

LINCOLN 
white petrolatum ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3045
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U) PETROLATUM76 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LAVENDER OIL (UNII: ZBP1YXW0H8)  
VITAMIN A (UNII: 81G40H8B0T)  
VITAMIN D (UNII: 9VU1KI44GP)  
LANOLIN (UNII: 7EV65EAW6H)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69636-3045-25 g in 1 PACKET; Type 0: Not a Combination Product01/10/2017
2NDC:69636-3045-328.3 g in 1 TUBE; Type 0: Not a Combination Product01/10/2017
3NDC:69636-3045-4113 g in 1 TUBE; Type 0: Not a Combination Product01/10/2017
4NDC:69636-3045-5425 g in 1 JAR; Type 0: Not a Combination Product01/10/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/10/2017
Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
Establishment
NameAddressID/FEIBusiness Operations
Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-3045)

Revised: 1/2017
Document Id: 45c37f14-ce77-523c-e054-00144ff88e88
Set id: 45c37f14-ce76-523c-e054-00144ff88e88
Version: 1
Effective Time: 20170110
 
Lincoln Pharmaceuticals Ltd.