ZINC OXIDE - zinc oxide ointment 
Sion Biotext Medical 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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Zinc Oxide Ointment

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      Skin Protectant

Uses:

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

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:

           For skin protectant:
           For diaper Rash:

Other information:

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Zinc Oxide OintmentZinc Oxide Ointment


ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-226
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
DIAZOLIDINYLUREA (UNII: H5RIZ3MPW4)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
MINERAL OIL (UNII: T5L8T28FGP)  
PETROLATUM (UNII: 4T6H12BN9U)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
SODIUM BORATE (UNII: 91MBZ8H3QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
CORN OIL (UNII: 8470G57WFM)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68786-226-016 in 1 CASE
1144 in 1 BOX
15 g in 1 PACKET
2NDC:68786-226-026 in 1 CASE
236 in 1 BOX
215 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2010
Labeler - Sion Biotext Medical Ltd (532775194)
Registrant - Dynarex Corporation (008124359)
Establishment
NameAddressID/FEIBusiness Operations
Sion Biotext Medical Ltd532775194manufacture

Revised: 1/2010
Document Id: c310d58b-765f-46fb-8814-49245c9b5734
Set id: 03d9cab3-ea90-47f6-9209-0e6622ec50e3
Version: 1
Effective Time: 20100122
 
Sion Biotext Medical Ltd