LINCOLN- zinc oxide cream 
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% w/w)

PURPOSE

Skin Protectant

USES

WARNINGS

FOR EXTERNAL USE ONLY

When using this product

Stop use and ask a doctor

Keep out of reach of children

DIRECTIONS

OTHER INFORMATION

INACTIVE INGREDIENTS

aloe vera leaf, alpha-tocopherol, ceteth-10, cetostearyl alcohol, cetyl alcohol, cholecalciferol, glycerin, lanolin, lavender, methyl paraben, mineral oil, paraffin, petrolatum, phenoxyethanol, polyethylene glycol 6000, polysorbate 60, propylparaben sodium, steareth-20, trolamine, vitamin A, water, FD&C Yellow No. 5, D&C Red No. 21

PACKAGE LABEL

Principal Display & Drug Facts panel

LINCOLN 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69636-3066
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
CETYL ALCOHOL (UNII: 936JST6JCN)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
LANOLIN (UNII: 7EV65EAW6H)  
PROPYLPARABEN SODIUM (UNII: 625NNB0G9N)  
STEARETH-20 (UNII: L0Q8IK9E08)  
CETETH-10 (UNII: LF9X1PN3XJ)  
PETROLATUM (UNII: 4T6H12BN9U)  
POLYETHYLENE GLYCOL 6000 (UNII: 30IQX730WE)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
TROLAMINE (UNII: 9O3K93S3TK)  
VITAMIN A (UNII: 81G40H8B0T)  
WATER (UNII: 059QF0KO0R)  
D&C RED NO. 21 (UNII: 08744Z6JNY)  
GLYCERIN (UNII: PDC6A3C0OX)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PARAFFIN (UNII: I9O0E3H2ZE)  
CHOLECALCIFEROL (UNII: 1C6V77QF41)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69636-3066-499.2 g in 1 TUBE; 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)

Revised: 1/2017
Document Id: 45c4d71e-99f9-18ce-e054-00144ff8d46c
Set id: 45c4d71e-99f8-18ce-e054-00144ff8d46c
Version: 1
Effective Time: 20170110
 
Lincoln Pharmaceuticals Ltd.