LINCOSHIELD- zinc oxide 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

Zinc Oxide 3.8%

Purpose

Skin Protectant

Uses

Warnings

FOR EXTERNAL USE ONLY

When using this product

Stop use and ask a doctor if

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

soiled diapers may be prolonged

Inactive Ingredients

Aloe Barbadensis Gel, Chloroxylenol, Cholecalciferol (Vitamin D3), Zea Mays Oil, Fragrance, Lanolin, Mineral Oil, Paraffin, Phenoxyethanol, Retinyl Palmitate (Vitamin A), Sodium Borate, Tocopherol Acetate (Vitamin E), Water, White Petrolatum

Product Label

LINCOSHIELD 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-8020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CORN OIL (UNII: 8470G57WFM)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CHLOROXYLENOL (UNII: 0F32U78V2Q)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
WATER (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69636-8020-4452 g in 1 JAR; Type 0: Not a Combination Product10/06/2016
2NDC:69636-8020-0100 g in 1 TUBE; Type 0: Not a Combination Product10/06/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34710/06/2016
Labeler - Lincoln Pharmaceuticals Ltd. (915839373)
Establishment
NameAddressID/FEIBusiness Operations
Lincoln Pharmaceuticals Ltd.915839373manufacture(69636-8020)

Revised: 10/2016
Document Id: 3e1f9d2e-c25a-4c42-e054-00144ff88e88
Set id: 3e1f9d2e-c259-4c42-e054-00144ff88e88
Version: 1
Effective Time: 20161005
 
Lincoln Pharmaceuticals Ltd.