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Barriere

WellSpring Pharmaceutical Corporation

Barriere


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Dimethicone, 20%

Skin Protectant

Temporarily protects and helps relieve chapped or cracked skin

▪ Helps protect from the drying effects of wind and cold weather

▪ Helps treat and prevent diaper rash

▪ Protects minor skin irritation due to diaper rash and helps seal out wetness

  For external use only

Do not use on

▪ Animal bites

▪ Deep or puncture wounds    

▪ Serious burns

When using this product

▪  do not get into eyes

Stop use and ask a doctor if

▪ Condition worsens                                      

▪ Symptoms last more than 7 days or clear up and occur again within a few days

Keep out of reach of children

For Skin Protection: Apply as needed      

▪ For Treatment or Prevention of Diaper Rash: Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry.  Apply cream liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

▪ Store at 20-25°C (68-77°F)

butylated hydroxytoluene, butylparaben, cetyl alcohol, edetate disodium, ethylparaben, fragrance, isobutylparaben, methylparaben, phenoxyethanol, propylene glycol, propylparaben, stearic acid, triethanolamine, water

Call 1-866-337-4500

Distributed by

WellSpring Pharmaceutical Corporation
Sarasota, FL 34243 USA
(c) WellSpring 2010

Package Label. Principal Display Panel

Barriere

Barriere

Dimethicone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:65197-426
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 0.2 g

Inactive Ingredients

Ingredient Name Strength
BUTYLATED HYDROXYTOLUENE
BUTYLPARABEN
CETYL ALCOHOL
EDETATE SODIUM
ETHYLPARABEN
isobutylparaben
METHYLPARABEN
PHENOXYETHANOL
propylene glycol
PROPYLPARABEN
STEARIC ACID
TROLAMINE
water

Product Characteristics

Color
WHITE (white)

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:65197-426-01 100 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2010-08-02


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