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Coolbottoms

pH R&D LLC

Cool bottoms DIAPER RASH CREAM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Dimethicone 1%

Purpose

Skin protectant

Coolbottoms 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

Coolbottoms

Dimethicone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:50952-001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 0.57 g

Inactive Ingredients

Ingredient Name Strength
water
Mineral Oil
petrolatum
sorbitol
SORBITAN SESQUIOLEATE
Lanolin Alcohols
PHENOXYETHANOL
magnesium hydroxide
ETHYLHEXYLGLYCERIN
BUTYLATED HYDROXYTOLUENE

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28 in 1 JAR
2 28 in 1 JAR
3 28 in 1 JAR
4 28 in 1 JAR
5 57 in 1 JAR
6 57 in 1 JAR
7 57 in 1 JAR
8 NDC:50952-001-03 24 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2010-04-25


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Be sure to consult your doctor before taking any medication!
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