DR SMITHS DIAPER RASH- zinc oxide spray

Dr Smiths Diaper Rash by

Drug Labeling and Warnings

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

Drug Details [pdf]

ACTIVE INGREDIENT

• Active Ingredient: Purpose
• Zinc Oxide 10%: Skin Protectant

INDICATIONS & USAGE

USES

• helps treat and prevent rash caused by adult incontinence
• protects chafed skin from wetness

WARNINGS

For external use only

When using this product

• do not get into eyes

Stop use and ask a doctor if

• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days

KEEP OUT OF REACH OF CHILDREN

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

DIRECTIONS

• cleanse the affected area
• allow to dry
• shake well before each use
• spray liberally onto affected area as often as needed

OTHER INFORMATION

• do not puncture or incinerate, contents under pressure.
• do not store at temperatures above 120°F
• store between 15°–30°C (59°–86°F)

INACTIVE INGREDIENTS

Aluminum starch octenylsuccinate, C12-15 alkyl lactate, caprylic/capric triglyceride, cetyl PEG/PPG-10/1 dimethicone, disiloxane, fragrance, hexyl laurate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, magnesium sulfate, methylparaben, octyldodecanol, octyldodecyl xyloside, peg-30 dipolyhydroxystearate, polyglyceryl-4 isostearate, polysorbate 60, polysorbate 80, propylene glycol, propylparaben, sorbitan oleate, squalane, thymol iodide, trans-1,3,3,3-tetrafluorprop-1-ene, triethoxycaprylylsilane, water

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

SPL UNCLASSIFIED SECTION

Manufactured for:
MISSION PHARMACAL COMPANY
San Antonio, TX 78230 1355

PRINCIPAL DISPLAY PANEL

Dr. Smith’s Rash and Skin Spray
NDC 0178–0345–03

INGREDIENTS AND APPEARANCE

DR SMITHS DIAPER RASH 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0178-0345
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
C12-15 ALKYL LACTATE (UNII: GC844VRD7E)
OCTYLDODECANOL (UNII: 461N1O614Y)
PEG-30 DIPOLYHYDROXYSTEARATE (UNII: 9713Q0S7FO)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MAGNESIUM SULFATE (UNII: DE08037SAB)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)
POLYGLYCERYL-4 ISOSTEARATE (UNII: 820DPX33S7)
HEXYL LAURATE (UNII: 4CG9F9W01Q)
THYMOL IODIDE (UNII: A51HJM3XSU)
SODIUM ACRYLOYLDIMETHYLTAURATE (UNII: 2T9Q6EKI0G)
SQUALANE (UNII: GW89575KF9)
POLYSORBATE 60 (UNII: CAL22UVI4M)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
1,3,3,3-TETRAFLUOROPROPENE, (1E)- (UNII: 5I2481UOO8)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0345-03	100 g in 1 BOTTLE, SPRAY

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/07/2014

Labeler - Mission Pharmacal Company (008117095)

Registrant - Mission Pharmacal Company (927726893)

Establishment
Name	Address	ID/FEI	Business Operations
FORMULATED SOLUTIONS, LLC		143266687	MANUFACTURE(0178-0345)