NDC 50952-001 Coolbottoms Diaper Rash

NDC Product Code 50952-001

NDC CODE: 50952-001

Proprietary Name: Coolbottoms Diaper Rash What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.

Product Characteristics

Color(s):
WHITE (C48325)

NDC Code Structure

NDC 50952-001-01

Package Description: 1 JAR in 1 BOX > 57 g in 1 JAR

NDC 50952-001-02

Package Description: 12 JAR in 1 BOX > 57 g in 1 JAR

NDC 50952-001-03

Package Description: 24 JAR in 1 BOX > 57 g in 1 JAR

NDC 50952-001-04

Package Description: 4 JAR in 1 BOX > 28 g in 1 JAR

NDC 50952-001-05

Package Description: 8 JAR in 1 BOX > 28 g in 1 JAR

NDC 50952-001-06

Package Description: 12 JAR in 1 BOX > 28 g in 1 JAR

NDC 50952-001-07

Package Description: 24 JAR in 1 BOX > 28 g in 1 JAR

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

NDC Product Information

Coolbottoms Diaper Rash with NDC 50952-001 is a product labeled by Ph R&d Llc. The product's dosage form is and is administered via form. The RxNorm Crosswalk for this NDC code indicates multiple RxCUI concepts are associated to this product: 1044936 and 200010.

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.

  • WATER (UNII: 059QF0KO0R)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • SORBITOL (UNII: 506T60A25R)
  • SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
  • LANOLIN ALCOHOLS (UNII: 884C3FA9HE)
  • PHENOXYETHANOL (UNII: HIE492ZZ3T)
  • MAGNESIUM HYDROXIDE (UNII: NBZ3QY004S)
  • ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
  • BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)

Product Labeler Information

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

Labeler Name: Ph R&d Llc
Labeler Code: 50952
Start Marketing Date: 04-25-2010 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: 12-31-2017 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.

Coolbottoms Diaper Rash Product Label Images

Coolbottoms 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

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

  • Helps treat diaper rashtemporarily protects and helps relieve chapped or cracked skinprotects chafed skin as associated with diaper rash and helps seal out wetness

Warnings

For external use only

When Using This Product

  • Keep out of eyes. Rinse eyes thoroughly with water to remove.

Directions

  • Change wet and soiled diapers promptlycleanse the diaper areaallow to dryapply cream liberally as often as necessary, especially at bedtime when exposure to wet diapers may be prolonged.

Inactive Ingredients

Water, Mineral Oil, White Petrolatum, Sorbitol, Ceresine, Sorbitan Sesquioleate, Lanolin Alcohol, Phenoxyethanol, Magnesium Hydroxide, Ethylhexylglycerin, BHT

Questions?

M-F CST Call: 1-877-725-RASH

* Please review the disclaimer below.