BARRIERE- dimethicone cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)

Available from:

WellSpring Pharmaceutical Corporation

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

OTC monograph final

Summary of Product characteristics

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._
----------
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 T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 519 7-426
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)
DIMETHICONE
0 .2 g i