BARRIERE- dimethicone cream

Barriere by

Drug Labeling and Warnings

Barriere by is a Otc medication manufactured, distributed, or labeled by WellSpring Pharmaceutical Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

BARRIERE 
dimethicone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65197-426
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE SODIUM (UNII: MP1J8420LU)
ETHYLPARABEN (UNII: 14255EXE39)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
METHYLPARABEN (UNII: A2I8C7HI9T)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
STEARIC ACID (UNII: 4ELV7Z65AP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	WHITE (white)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65197-426-01	100 g in 1 TUBE; Type 0: Not a Combination Product	08/02/2010	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part347	08/02/2010	12/31/2020

Labeler - WellSpring Pharmaceutical Corporation (110999054)