NDC 0178-0345 Dr Smiths Diaper Rash

NDC Product Code 0178-0345

NDC 0178-0345-03

Package Description: 100 g in 1 BOTTLE, SPRAY

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

NDC Product Information

Dr Smiths Diaper Rash with NDC 0178-0345 is a product labeled by Mission Pharmacal Company. The generic name of Dr Smiths Diaper Rash is . The product's dosage form is and is administered via form.

Labeler Name: Mission Pharmacal Company

Inactive Ingredient(s)

About the Inactive Ingredient(s)
The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product.

  • 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)

Product Labeler Information

What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.

Labeler Name: Mission Pharmacal Company
Labeler Code: 0178
Start Marketing Date: 04-07-2014 What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.

Listing Expiration Date: 12-31-2019 What is the Listing Expiration Date?
This is the date when the listing record will expire if not updated or certified by the product labeler.

Exclude Flag: I - INACTIVATED, the listing data was inactivated by the FDA. What is the NDC Exclude Flag?
This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".

* Please review the disclaimer below.

Dr Smiths Diaper Rash Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Otc - Active Ingredient

Active IngredientPurposeZinc Oxide 10%Skin Protectant

Uses

  • Helps treat and prevent rash caused by adult incontinenceprotects chafed skin from wetness

Warnings

  • For external use onlyWhen using this productdo not get into eyesStop use and ask a doctor ifcondition worsenssymptoms last more than 7 days or clear up and occur again
  • Within a few days

Otc - 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 areaallow to dryshake well before each usespray 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°Fstore 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, waterTo report a serious adverse event or obtain
product information, call (210) 696–8400.

Other

Manufactured
for:MISSION PHARMACAL COMPANYSan Antonio,
TX 78230 1355

* Please review the disclaimer below.