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zinc oxide by Sion Biotext Medical Ltd

Medically reviewed on Jan 22, 2018

Dosage form: ointment
Ingredients: ZINC OXIDE 1.8g in 100g
Labeler: Sion Biotext Medical Ltd
NDC Code: 68786-226

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.

Zinc Oxide Ointment

Active Ingredient               Purpose

Zinc Oxide (1.8% w/w)      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:           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

Other information:
  • Store at room temperature
  • avoid excessive heat
  • contains color additives including FDC yellow # 5

Principal Display Panel

Zinc Oxide Ointment


ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68786-226
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE1.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
CETYL ALCOHOL 
DIAZOLIDINYLUREA 
LANOLIN 
METHYLPARABEN 
MINERAL OIL 
PETROLATUM 
VITAMIN A PALMITATE 
SODIUM BORATE 
STEARIC ACID 
.ALPHA.-TOCOPHEROL ACETATE, D- 
CORN OIL 
WATER 
FD&C YELLOW NO. 5 
Packaging
#Item CodePackage Description
1NDC:68786-226-016 BOX (BOX) in 1 CASE
1144 PACKET (PACKET) in 1 BOX
15 g in 1 PACKET
2NDC:68786-226-026 BOX (BOX) in 1 CASE
236 PACKET (PACKET) 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/FEIOperations
Sion Biotext Medical Ltd532775194manufacture

 
Sion Biotext Medical Ltd

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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