ANTIBACTERIAL HAND GEL Tootsie Roll Lime

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

JFL ENTERPRISES, INC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Decrease bacteria on hands

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER LIME- 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 TOOTSIE ROLL LIME
ACTIVE INGREDIENT
Alcohol 62%
PURPOS E
Antiseptic Hand Sanitizer
US E
Decrease bacteria on hands
WARNINGS
External Use Only. DO NOT EAT.
KEEP OUT OF REACH OF CHILDREN
if swallowed get medical help or contact a Poison Control Center right
away.
Flammable: Keep away from flame or high heat
DIRECTIONS
Rub hands thoroughly with product and allow to dry.
INACTIVE INGREDIENT
Water, Glycerin, Propylene Glycol, Carbomer, Triethanolamine,
Fragrance, Blue NO.1, Yellow NO.5
STOP AND ASK A DOCTOR IF
Irritation or redness develop.
HAND SANITIZER LIME (ALCOHOL) GEL
HAND SANITIZER LIME
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71246 -50 28
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)
LIME O IL (UNII: UZH29 XGA8 G)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:71246 -50 28 -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
JFL ENTERPRISES, INC
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION
MARKE TING START DATE
MARKE TING END DATE
OTC mo no graph no t final
pa rt333A
0 1/0 1/20 19
0 6 /30 /20 20
LABELER -
JFL ENT ERPRISES, INC (01