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Name:Barriere
Manufacturer:Wellspring Pharmaceutical Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Barriere

BARRIERE - dimethicone cream 
WellSpring Pharmaceutical Corporation

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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Barriere

Active ingredient

Dimethicone, 20%

Purpose

Skin Protectant

Use

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

Warning

 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

Directions

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.

Other information

▪ Store at 20-25°C (68-77°F)

Inactive ingredients

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

Questions?

Call 1-866-337-4500

Distributed by

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

Package Label. Principal Display Panel

Tube label

BARRIERE 
dimethicone cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:65197-426
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 0.2 g  in 1 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) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:65197-426-01 100 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part347 08/02/2010

Labeler - WellSpring Pharmaceutical Corporation (110999054)
Establishment
Name Address ID/FEI Operations
WellSpring Pharmaceutical Canada Corp. 251086799 ANALYSIS, LABEL, MANUFACTURE, PACK
Establishment
Name Address ID/FEI Operations
WellSpring Pharmaceutical Corporation 110999054 MANUFACTURE

Revised: 12/2010 WellSpring Pharmaceutical Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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