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DR SMITHS DIAPER

Medically reviewed on Dec 4, 2017

Dosage form: ointment
Ingredients: ZINC OXIDE 100mg in 1g
Labeler: Mission Pharmacal
NDC Code: 0178-0330

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.

Drug Facts

Active Ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

Warnings

For external use only

When using this product, avoid contact with the eyes.

See a doctor if condition lasts more than 7 days.

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

Directions

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

Storage and Handling

Store between 15 0 and 30 0 C (59 0 and 86 0 F)

Inactive Ingredients

Beeswax, lanolin, mineral oil, olive oil, paraffin wax, petrolatum, purified water, thymol iodide

To report a serious adverse event of obtain product information, call (201)-696-8400

DR SMITHS DIAPER 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0330
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
LANOLIN 
MINERAL OIL 
OLIVE OIL 
PARAFFIN 
PETROLATUM 
WATER 
THYMOL IODIDE 
Packaging
#Item CodePackage Description
1NDC:0178-0330-0385 g in 1 TUBE
2NDC:0178-0330-0256.7 g in 1 JAR
3NDC:0178-0330-08226.8 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34703/01/2010
Labeler - Mission Pharmacal (008117095)
Registrant - Mission Pharmacal (008117095)
Establishment
NameAddressID/FEIOperations
Nexgen Pharma, Inc.079424083manufacture(0178-0330), analysis(0178-0330), pack(0178-0330), label(0178-0330)
Establishment
NameAddressID/FEIOperations
Mission Pharmacal Company927726893manufacture(0178-0330), analysis(0178-0330), label(0178-0330), pack(0178-0330)

 
Mission Pharmacal

Further information

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

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