Coolbottoms Diaper Rash

Dosage form: cream
Ingredients: Dimethicone 0.57g in 57g
Labeler: pH R&D LLC
NDC Code: 50952-001

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.

Cool
bottoms®
DIAPER RASH CREAM

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses
  • helps treat diaper rash
  • temporarily protects and helps relieve chapped or cracked skin
  • protects 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.

Stop use and ask a doctor if:

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again in 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 the diaper area
  • allow to dry
  • apply 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

Distributed by
GinJen
Hammond, LA 70401

PRINCIPAL DISPLAY PANEL - 57g jar carton

developed by a
pediatrician

PATENTED
Cool
bottoms®
DIAPER RASH CREAM
skin protectant
cools and soothes

NET WT 2 OZ (57g)

COOLBOTTOMS   DIAPER RASH
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (Dimethicone) Dimethicone0.57 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
Water 
Mineral Oil 
Petrolatum 
Sorbitol 
Sorbitan Sesquioleate 
Lanolin Alcohols 
Phenoxyethanol 
Magnesium Hydroxide 
Ethylhexylglycerin 
Butylated Hydroxytoluene 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50952-001-044 JAR (JAR) in 1 BOX
128 g in 1 JAR
2NDC:50952-001-058 JAR (JAR) in 1 BOX
228 g in 1 JAR
3NDC:50952-001-0612 JAR (JAR) in 1 BOX
328 g in 1 JAR
4NDC:50952-001-0724 JAR (JAR) in 1 BOX
428 g in 1 JAR
5NDC:50952-001-011 JAR (JAR) in 1 BOX
557 g in 1 JAR
6NDC:50952-001-0212 JAR (JAR) in 1 BOX
657 g in 1 JAR
7NDC:50952-001-0324 JAR (JAR) in 1 BOX
757 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34704/25/2010
Labeler - pH R&D LLC (833115764)

Revised: 11/2010
 
pH R&D LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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