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

Dr. Smith's Adult Barrier Spray 3.5 oz.

Dr. Smith's Adult Barrier Spray 6 oz.

INGREDIENTS AND APPEARANCE

DR SMITHS DIAPER RASH 
zinc oxide spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0178-0348
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)
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)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0178-0348-06	170 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/07/2014
2	NDC: 0178-0348-03	100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product	04/07/2014

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(0178-0348)