RUGBY ZINC OXIDE- zinc oxide ointment 
Rugby Laboratories

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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Drug Facts

Active ingredient

Zinc oxide 20%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product, avoid contact with the eyes

Stop use and ask a doctor if condition worsens or does not improve within 7 days

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

Inactive ingredients

mineral oil, petrolatum

Questions or comments?

Call 1-800-645-2158 9 am - 5 pm EST, Monday – Friday

Store at room temperature 15° - 30°C (59° - 86°F).

R0507

Principal Display Panel – Jar Label

Rugby® NDC 0536-5700-98
SKIN PROTECTANT

Zinc Oxide
Ointment USP
provides soothing relief from poison ivy,
oak and sumac
Treats and prevents diaper rash

Net Wt 1 lb (454 g)

Mfd for: Rugby Laboratories, Inc.
Duluth, Georgia 30097

Principal Display Panel – Jar Label
RUGBY ZINC OXIDE 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-5700
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
MINERAL OIL 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5700-98454 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/23/2004
Labeler - Rugby Laboratories (191427277)
Registrant - Faria Limited dba Sheffield Pharmaceuticals (151177797)
Establishment
NameAddressID/FEIBusiness Operations
Faria LLC dba Sheffield Pharmaceuticals151177797MANUFACTURE(0536-5700)

Revised: 1/2013
Document Id: 01586357-6c74-4180-96a4-9a78840f6f2f
Set id: 2f70f5e3-6b1f-4848-8031-c686ee2d8cc3
Version: 1
Effective Time: 20130111
 
Rugby Laboratories