BARRIERE - dimethicone cream 
WellSpring Pharmaceutical Corporation

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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

BARRIERE  dimethicone   cream

Product Information Product Type HUMAN OTC DRUG NDC Product Code (Source) 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 # NDC Package Description Multilevel Packaging 1 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: 05/2010WellSpring Pharmaceutical Corporation