DR SMITHS DIAPER- zinc oxide ointment 
MainPointe Pharmaceuticals, LLC

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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Dr. Smith's Diaper Rash Ointment

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 (502)709-7544.

3 oz. Carton

DR SMITHS DIAPER 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71269-006
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:71269-006-0385 g in 1 TUBE; Type 0: Not a Combination Product01/19/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34701/19/2018
Labeler - MainPointe Pharmaceuticals, LLC (080544378)
Registrant - Mission Pharmacal (927726893)

Revised: 2/2020
Document Id: 9f5881ad-f3b1-7ab7-e053-2a95a90a54e7
Set id: 9f5882f7-d942-5b70-e053-2995a90aefcb
Version: 1
Effective Time: 20200224
 
MainPointe Pharmaceuticals, LLC