CMC ZINC OXIDE- zinc oxide ointment 
SKYLARK CMC PRIVATE LIMITED

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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SKYLARK ZINC OXIDE 20% DIAPER RASH CREAM

Active ingredient

Zinc Oxide (20% w/w)

Purpose

Skin Protectant

Purpose

Warnings

For external use only

When using this product

Stop use and ask a doctor if

Keep out of reach of children

Directions

Other information

Inactive ingredients

cetostearyl alcohol, cetomacrogol 1000, light liquid paraffin, white soft paraffin

PACKAGE LABEL

Drug factFront display

CMC ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71168-3040
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE20 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CETETH-20 (UNII: I835H2IHHX)  
PETROLATUM (UNII: 4T6H12BN9U)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71168-3040-328 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
2NDC:71168-3040-456 g in 1 TUBE; Type 0: Not a Combination Product09/01/2017
3NDC:71168-3040-5425 g in 1 JAR; Type 0: Not a Combination Product09/01/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34709/01/2017
Labeler - SKYLARK CMC PRIVATE LIMITED (650174824)

Revised: 9/2017
Document Id: 58eec6dd-be0f-bafc-e053-2a91aa0a97cf
Set id: 58eec6dd-be0e-bafc-e053-2a91aa0a97cf
Version: 1
Effective Time: 20170911
 
SKYLARK CMC PRIVATE LIMITED