ANTIBACTERIAL HAND GEL LEMON

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)

Tilgjengelig fra:

JFL ENTERPRISES, INC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

Decrease bacteria on hands

Autorisasjon status:

OTC monograph not final

Preparatomtale

HAND SANITIZER LEMON- ALCOHOL GEL
JFL ENTERPRISES, INC
_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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ANTIBACTERIAL HAND GEL LEMON
ACTIVE INGREDIENT
Alcohol 62%
PURPOS E
Antiseptic Hand Sanitizer
US E
Decrease bacteria on hands
WARNINGS
External Use Only. DONO EAT.
KEEP OUT OF REACH OF CHILDREN
if swallowed
get medical help or contact a Poison Control Center right away.
DIRECTIONS
Rub hands thoroughly with product and allow to dry.
INACTIVE INGREDIENT
Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine,
Fragrance, Yellow NO.5
STOP AND ASK A DOCTOR IF
Irritation or redness develop.
HAND SANITIZER LEMON DOTS
HAND SANITIZER LEMON
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71246 -50 0 0
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)
ALCOHOL
6 2 mL in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
WATER (UNII: 0 59 QF0 KO0 R)
GLYCERIN (UNII: PDC6 A3C0 OX)
CARBO MER HO MO PO LYMER TYPE B ( ALLYL SUCRO SE CRO SSLINKED) (UNII:
Z135WT9 20 8 )
TRIETHANO LAMINE 2 -CYCLO HEXYL-4 ,6 -DINITRO PHENO LATE (UNII:
N2TK31JIAH)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
LEMO N (UNII: 24RS0 A9 8 8 O)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:71246 -50 0 0 -1
40 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 1/0 1/20 19
0 6 /30 /20 20
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
JFL ENTERPRISES, INC
OTC mo no graph no t final
pa rt333A
0 2/0 1/20 17
0 6 /30 /20 20
LABELER -
JFL ENT ERPRISES, INC (010967011)
REGISTRANT -
JFL ENT ERPRISES, INC (010967011)
ESTABLISHMENT
NAME
AD D RE S S
ID/FEI
BUSINE SS OPE RAT