COOLBOTTOMS  DIAPER RASH - dimethicone cream 
pH R&D LLC

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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 Type HUMAN OTC DRUG NDC Product Code (Source) 50952-001 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Dimethicone (Dimethicone) Dimethicone 0.57 g  in 57 g

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 50952-001-01 1 JAR In 1 BOX contains a JAR 1 1 g In 1 JAR This package is contained within the BOX (50952-001-01)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	04/25/2010

Labeler - pH R&D LLC (833115764)

Revised: 04/2010pH R&D LLC