Your browser does not support JavaScript! ZINC OXIDE OINTMENT [DYNAREX CORPORATION]
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RxNorm Names

ZINC OXIDE ointment
[Dynarex Corporation]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

Section Text

Active Ingredient                            Purpose

Zinc Oxide (200mg in each gram)   Skin Protectant

Purpose:

  • Helps treat and prevent diaper rash.
  • 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:

  • conditions worsens
  • symptoms last more than 7 days or clear up and occur again in a few days, consult a physician.
  • over large areas of the body
  • if you are allergic to any of these ingredients

Do not use on:

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

For diaper rash:

  • change wet and soiled diapers promptly
  • cleanse the diaper area and allow to dry
  • apply ointment liberally with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged

For poison ivy, poison oak, poison sumac:

  • apply liberally as often as needed

Inactive Ingredients

Cetostearyl alcohol, Cetomacrogal 1000, Light Liquid Paraffin, White Soft Paraffin

Principal Display

zinc oxide

zinc.jpg

ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE200 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CETOSTEARYL ALCOHOL 
CETETH-20 
LIGHT MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-222-0372 in 1 CASE
128.34 g in 1 TUBE
2NDC:67777-222-0172 in 1 CASE
256.68 g in 1 TUBE
3NDC:67777-222-0212 in 1 CASE
3425.1 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/16/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)
Establishment
NameAddressID/FEIBusiness Operations
Galentic Pharma (India) Pvt. Ltd.864201135manufacture(67777-222)

Revised: 4/2014
 
Dynarex Corporation

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