TOPICAL ANESTHETIC- benzocaine gel, dentifrice

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

Benzocaine (UNII: U3RSY48JW5) (Benzocaine - UNII:U3RSY48JW5)

متاح من:

Patterson Dental

INN (الاسم الدولي):

Benzocaine

تركيب:

Benzocaine 220 mg in 1 g

طريقة التعاطي:

DENTAL

نوع الوصفة الطبية :

PRESCRIPTION DRUG

ملخص المنتج:

Store at controlled room temperature 59-86°F (15-30°C).

الوضع إذن:

OTC monograph not final

خصائص المنتج

TOPICAL ANESTHETIC BANANA- BENZOCAINE GEL, DENTIFRICE
PATTERSON DENTAL
_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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TOPICAL ANESTHETIC
BANANA FLAVOR GEL
INGREDIENTS
Each gram of 20% benzocaine gel contains between 180-220 mg benzocaine
U.S.P., in a water soluble
base of PEG 3350 U.S.P., PEG 400 U.S.P., flavor, sodium saccharin
U.S.P., and FD&C Red #40.
USUAL DOSAGE
For oral mucosal use only as directed by a dentist.
CAUTION
Contains FD&C Yellow #5 (tartrazine) which may cause an allergenic
response. Federal law prohibits
dispensing without a prescription.
WARNING
Keep out of reach of children. Do not use on people with known
allergies to benzocaine and PABA
compounds.
Store at controlled room temperature 59-86°F (15-30°C).
MADE IN U.S.A.
Distributed by:
PATTERSON
DENTAL
_Corporate Office_
1031 Mendota Heights Road
Saint Paul, MN 55120
PATTERSON
DENTAL /
Montréal Québec
H3M 3E6
PRINCIPAL DISPLAY PANEL - 29.6 ML LABEL
PATTERSON
DENTAL
TOPICAL ANESTHETIC
BANANA FLAVOR GEL
CONTAINS 20% BENZOCAINE
For Professional Use Only
Net Contents 1 fl oz (29.6 mL)
Reorder Number
_089-9989_
TOPICAL ANESTHETIC BANANA
benzocaine gel, dentifrice
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN PRESCRIPTION DRUG
ITE M CODE (SOURCE )
NDC:50 227-2116
ROUTE OF ADMINISTRATION
DENTAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZO CA INE (UNII: U3RSY48 JW5) (Benzo caine - UNII:U3RSY48 JW5)
Be nz o c a ine
220 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)
PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)
SACCHARIN SO DIUM (UNII: SB8 ZUX40 TY)
FD&C RED NO . 4 0 (UNII: WZB9 127XOA)
PRODUCT CHARACTERISTICS
COLOR
S CORE
S HAP E
S IZ E
FLAVOR
BANANA
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:50 227-2116 -1
34 g in 1 J