DR SMITHS DIAPER RASH- zinc oxide spray 
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.

----------

Drug Facts

Active IngredientPurpose
Zinc Oxide 10%Skin Protectant

USES

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out 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

  • change wet and soiled diapers promptly
  • cleanse diaper area
  • allow to dry
  • shake well before each use
  • spray liberally onto affected area as often as needed or with each diaper change, especially at bedtime or anytime when exposure to wet diaper may be prolonged

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

DRS Diaper Rash Spray

DR SMITHS DIAPER RASH 
zinc oxide spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0178-0340
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
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0178-0340-03100 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product04/07/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/07/201412/23/2021
Labeler - Mission Pharmacal Company (008117095)
Registrant - Mission Pharmacal Company (927726893)
Establishment
NameAddressID/FEIBusiness Operations
FORMULATED SOLUTIONS, LLC143266687manufacture(0178-0340)

Revised: 12/2021
 
Mission Pharmacal Company