DR SMITHS DIAPER- zinc oxide ointment

DR SMITHS DIAPER by

Drug Labeling and Warnings

DR SMITHS DIAPER by is a Otc medication manufactured, distributed, or labeled by Mission Pharmacal, Nexgen Pharma, Inc., Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient

Zinc Oxide 10%

PURPOSE

Purpose

Skin Protectant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

WHEN USING

When using this product, avoid contact with the eyes.

STOP USE

See a doctor if condition lasts more than 7 days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

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 INGREDIENT

Inactive Ingredients

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

OTHER SAFETY INFORMATION

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DR SMITHS DIAPER 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0178-0330
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0330-03	85 g in 1 TUBE; Type 0: Not a Combination Product	03/01/2010
2	NDC: 0178-0330-02	56.7 g in 1 JAR; Type 0: Not a Combination Product	03/01/2010
3	NDC: 0178-0330-08	226.8 g in 1 JAR; Type 0: Not a Combination Product	03/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	03/01/2010

Labeler - Mission Pharmacal (008117095)

Registrant - Mission Pharmacal (008117095)

Establishment
Name	Address	ID/FEI	Business Operations
Nexgen Pharma, Inc.		079424083	manufacture(0178-0330) , analysis(0178-0330) , pack(0178-0330) , label(0178-0330)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	manufacture(0178-0330) , analysis(0178-0330) , label(0178-0330) , pack(0178-0330)