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Barriere

Medically reviewed on December 28, 2017.

Dosage form: cream
Ingredients: DIMETHICONE 0.2g in 1g
Labeler: WellSpring Pharmaceutical Corporation
NDC Code: 65197-426

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.

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
BARRIERE 
dimethicone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65197-426
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (DIMETHICONE) DIMETHICONE0.2 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE 
BUTYLPARABEN 
CETYL ALCOHOL 
EDETATE SODIUM 
ETHYLPARABEN 
ISOBUTYLPARABEN 
METHYLPARABEN 
PHENOXYETHANOL 
PROPYLENE GLYCOL 
PROPYLPARABEN 
STEARIC ACID 
TROLAMINE 
WATER 
Product Characteristics
ColorWHITE (white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:65197-426-01100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart34708/02/2010
Labeler - WellSpring Pharmaceutical Corporation (110999054)
Establishment
NameAddressID/FEIOperations
WellSpring Pharmaceutical Canada Corp.251086799ANALYSIS, LABEL, MANUFACTURE, PACK
Establishment
NameAddressID/FEIOperations
WellSpring Pharmaceutical Corporation110999054MANUFACTURE

 
WellSpring Pharmaceutical Corporation

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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