DR. SMITHS RASH AND SKIN- zinc oxide ointment

Dr. Smiths Rash and Skin by

Drug Labeling and Warnings

Dr. Smiths Rash and Skin by is a Otc medication manufactured, distributed, or labeled by Mission Pharmacal Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Drug Facts

• Active Ingredient: Purpose
• Petrolatum 57%: Skin Protectant
• Lanolin 16%: Skin Protectant

DOSAGE & ADMINISTRATION

PURPOSE

Uses

temporarily protest minor:

• cuts
• scrapes
• burns

INDICATIONS & USAGE

Temporarily protects and helps relieve chapped, chafed, or cracked skin.

Helps protect from the dying effects of wind and cold weather.

Helps treat and prevent rash caused by adult incontinence.

WARNINGS

Warnings

For external use only.

WHEN USING

When using this product, avoid contact with eyes.

ASK DOCTOR

See a doctor if condition lasts more than 7 days.

DO NOT USE

Do not use on

• deep or puncture wounds
• animal bites
• serious burns

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.

PURPOSE

Directions

Apply as needed to affected area.

QUESTIONS

Other Information

Store at 20° – 25°C (68° – 77° F)

INACTIVE INGREDIENT

beeswax, mineral oil, olive oil, paraffin wax, purified water, thymol iodide, zinc oxide.

STOP USE

To report a serious adverse event or obtain product information, call (210) 696-8400

MISSION PHARMACAL COMPANY
San Antonio, TX 78230-1355

51023
Rev 011120

PRINCIPAL DISPLAY PANEL

Dr Smith’s Rash+Skin Ointment Carton
NDC: 0178-0370-03

INGREDIENTS AND APPEARANCE

DR. SMITHS RASH AND SKIN 
zinc oxide ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0178-0370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)	57.18 g  in 100 g
LANOLIN (UNII: 7EV65EAW6H)	16.05 g  in 100 g
ZINC OXIDE (UNII: SOI2LOH54Z)	10 g  in 100 g
MINERAL OIL (UNII: T5L8T28FGP)	6.60 g  in 100 g
WATER (UNII: 059QF0KO0R)	4.60 g  in 100 g
WHITE WAX (UNII: 7G1J5DA97F)	2.07 g  in 100 g
OLIVE OIL (UNII: 6UYK2W1W1E)	2 g  in 100 g
THYMOL IODIDE (UNII: A51HJM3XSU)	1 g  in 100 g
PARAFFIN (UNII: I9O0E3H2ZE)	.5 g  in 100 g

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0370-03	1 in 1 CARTON
1		100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	05/01/2013

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name	Address	ID/FEI	Business Operations
Mission Pharmacal Company		927726893	MANUFACTURE(0178-0370)