DR SMITHS DIAPER- zinc oxide ointment 
Mission Pharmacal

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Dr. Smith’s Diaper Rash Ointment

Active Ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

Warnings

For external use only

When using this product,avoid contact with the eyes.

See a doctorif 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

Storage and Handling

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

Inactive Ingredients

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

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

Carton

DR SMITHS DIAPER 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0330
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE100 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX (UNII: 2ZA36H0S2V)  
LANOLIN (UNII: 7EV65EAW6H)  
MINERAL OIL (UNII: T5L8T28FGP)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PARAFFIN (UNII: I9O0E3H2ZE)  
PETROLATUM (UNII: 4T6H12BN9U)  
WATER (UNII: 059QF0KO0R)  
THYMOL IODIDE (UNII: A51HJM3XSU)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0330-0385 g in 1 TUBE; Type 0: Not a Combination Product10/05/2023
2NDC:0178-0330-0256.7 g in 1 JAR; Type 0: Not a Combination Product03/01/201010/05/2023
3NDC:0178-0330-08226.8 g in 1 JAR; Type 0: Not a Combination Product03/01/201010/05/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01603/01/2010
Labeler - Mission Pharmacal (008117095)
Registrant - Mission Pharmacal (008117095)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893analysis(0178-0330) , manufacture(0178-0330) , label(0178-0330) , pack(0178-0330)

Revised: 10/2023
Document Id: 06f91e45-38a3-235c-e063-6294a90afbe6
Set id: 7705b182-acf7-4195-9996-7d9fcdfbf055
Version: 9
Effective Time: 20231005
 
Mission Pharmacal