TOPICAL ANESTHETIC MINT benzocaine gel

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

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

Dostupné z:

Safco Dental Supply Co.

INN (Medzinárodný Name):

Benzocaine

Zloženie:

Benzocaine 200 mg in 1 g

Typ predpisu:

OTC DRUG

Stav Autorizácia:

OTC monograph not final

Súhrn charakteristických

TOPICAL ANESTHETIC MINT- BENZOCAINE GEL
SAFCO DENTAL SUPPLY CO.
_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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SENSICAINE TOPICAL ANESTHETIC GEL MINT FLAVOR
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 D&C Green #5.
USUAL DOSAGE
For oral mucosal use only as directed by a dentist.
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).
CAUTION
Federal law prohibits dispensing without a prescription.
_Distributed by:_
Safco Dental Supply Co.
Buffalo Grove, IL 60089
800-621-2178
www.safcodental.com
PRINCIPAL DISPLAY PANEL - JAR LABEL
SAFCO
SENS ICAINE
Topical Anesthetic Gel
MINT FLAVOR
Contains 20% Benzocaine
_For Professional Use Only_
1 oz. (34 g)
TOPICAL ANESTHETIC MINT
benzocaine gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 7239 -0 20 3
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
20 0 mg in 1 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PO LYETHYLENE GLYCO L 4 0 0 (UNII: B6 9 78 9 4SGQ)
SA CCHA RIN SO DIUM (UNII: SB8 ZUX40 TY)
PO LYETHYLENE GLYCO L 3 3 50 (UNII: G2M7P15E5P)
WA TER (UNII: 0 59 QF0 KO0 R)
D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)
PRODUCT CHARACTERISTICS
COLOR
gre e n
S CORE
S HAP E
S IZ E
FLAVOR
MINT
IMPRINT CODE
CONTAINS
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:6 7239 -0 20 3-1
34 g in 1 JAR; Type 0 : No t a Co mbinatio n Pro duct
0 8 /0 6 /20 12
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING STAR