DR. SMITHS RASH AND SKIN- zinc oxide ointment 
Mission Pharmacal Company

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® Rash+Skin

Drug Facts

Active IngredientPurpose
Petrolatum 57%Skin Protectant
Lanolin 16%Skin Protectant

Uses

temporarily protest minor:

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

For external use only.

When using this product, avoid contact with eyes.

See a doctor if condition lasts more than 7 days.

Do not use on

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

Apply as needed to affected area.

Other Information

Store at 20° – 25°C (68° – 77° F)

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

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

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

drs-t25912-1112-dr-smiths-rash-and-skin-3-oz-ctn-fnl-vp2-ew

drs-t25912-1112-dr-smiths-rash-and-skin-3-oz-ctn-fnl-vp2-ew2
DR. SMITHS RASH AND SKIN 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0370
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0370-031 in 1 CARTON
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34805/01/2013
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
Mission Pharmacal Company927726893MANUFACTURE(0178-0370)

Revised: 4/2013
Document Id: e6e61eea-73a0-3936-c648-b87771c24102
Set id: e6e61eea-73a0-3936-c648-b87771c24102
Version: 1
Effective Time: 20130403
 
Mission Pharmacal Company