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Dr Smiths Diaper Rash by Mission Pharmacal Company

Dosage form: spray
Ingredients: ZINC OXIDE 10g in 100g
Labeler: Mission Pharmacal Company
NDC Code: 0178-0348

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.

Drug Facts

Active IngredientPurpose
Zinc Oxide 10%Skin Protectant

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. 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.

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.

DR SMITHS DIAPER RASH 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0348
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
C12-15 ALKYL LACTATE 
OCTYLDODECANOL 
PEG-30 DIPOLYHYDROXYSTEARATE 
PROPYLENE GLYCOL 
DIMETHICONE 
WATER 
POLYGLYCERYL-4 ISOSTEARATE 
HEXYL LAURATE 
THYMOL IODIDE 
SODIUM ACRYLOYLDIMETHYLTAURATE 
SQUALANE 
POLYSORBATE 60 
POLYSORBATE 80 
SORBITAN MONOOLEATE 
METHYLPARABEN 
PROPYLPARABEN 
1,3,3,3-TETRAFLUOROPROPENE, (1E)- 
MEDIUM-CHAIN TRIGLYCERIDES 
MAGNESIUM SULFATE, UNSPECIFIED FORM 
Packaging
#Item CodePackage Description
1NDC:0178-0348-06170 g in 1 BOTTLE, SPRAY
2NDC:0178-0348-03100 g in 1 BOTTLE, SPRAY
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/07/2014
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIOperations
FORMULATED SOLUTIONS, LLC143266687manufacture(0178-0348)

 
Mission Pharmacal Company

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Medically reviewed on Dec 5, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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