COOLBOTTOMS  DIAPER RASH- dimethicone cream 
pH R&D LLC

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.

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Cool
bottoms®
DIAPER RASH CREAM

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Uses

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

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)

Principal Display Panel - 57g jar carton
COOLBOTTOMS   DIAPER RASH
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50952-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone0.57 g  in 57 g
Inactive Ingredients
Ingredient NameStrength
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 Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50952-001-044 in 1 BOX
128 g in 1 JAR
2NDC:50952-001-058 in 1 BOX
228 g in 1 JAR
3NDC:50952-001-0612 in 1 BOX
328 g in 1 JAR
4NDC:50952-001-0724 in 1 BOX
428 g in 1 JAR
5NDC:50952-001-011 in 1 BOX
557 g in 1 JAR
6NDC:50952-001-0212 in 1 BOX
657 g in 1 JAR
7NDC:50952-001-0324 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
Document Id: cadd20c2-a235-431a-b13b-13fbc102e6cf
Set id: 38fcc371-0eab-46e1-a98a-3784e12aa9af
Version: 2
Effective Time: 20101119
 
pH R&D LLC