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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Dynashield Ointment

Active Ingredient               Zinc Oxide (1.8% w/w)     

Purpose

Skin Protectant

Uses

Helps treat and prevent diaper rash

Temporarily protects

minor cuts

scrapes and

burns

dries the oozing and weeping of

poison ivy

poison oak

poison sumac

Warnings:

For External Use Only.

When using this product:

Do not get in eyes.

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician

Keep out of reach of children.

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

Directions

  • Apply Liberally as needed
  • For diaper rash
  • change wet and soiled diapers promptly
  • allow to dry

Inactive ingredients

CETYL ALCOHOL, DIAZOLIDINYLUREA, LANOLIN, METHYLPARABEN, MINERAL OIL, PETROLATUM, SODIUM BORATE, STEARIC ACID

Directions:

           For skin protectant:


  • Apply liberally as needed

           For diaper Rash:


  • change wet and soiled diapers promptly
  • allow to dry
  • apply ointment liberally with each diaper change

Principal Display Panel

Dynarex Dynashield

Label

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-228
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)  
DIAZOLIDINYL UREA (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:68786-228-016 in 1 CASE02/01/201012/31/2013
1144 in 1 BOX
15 g in 1 PACKET; Type 0: Not a Combination Product
2NDC:68786-228-026 in 1 CASE02/01/201012/31/2013
236 in 1 BOX
215 g in 1 PACKET; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/201012/31/2013
Labeler - Sion Biotext Medical Ltd (532775194)

Revised: 2/2018
 
Sion Biotext Medical Ltd