HAND SANITIZER LIME- alcohol gel

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._
----------
ANTIBACTERIAL HAND GEL LIME
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
Carbomer, Glycerin, Jojoba Particles, Lime Extract, Pigment Red
GB106-3040, Pigment Yellow 109C,
Propylene Glycol, Triethanolamine, Water.
STOP AND ASK A DOCTOR IF
Irritation or redness develop.
HAND SANITIZER (ALCOHOL) GEL
HAND SANITIZER LIME
alcohol gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71246 -40 0 1
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)
PIGMENT RED 1 (UNII: D54Q24K2EI)
PIGMENT YELLO W 10 9 (UNII: AFB0 QQM2VZ)
JO JO BA ACID (UNII: MO7HV0 4S9 Y)
LIME O IL (UNII: UZH29 XGA8 G)
JFL ENTERPRISES, INC
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:71246 -40 0 1-1
40 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 2/20 17
MARKETING INFORMATION
MARKE TING CATE GORY
APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE
MARKE TING END DATE
OTC MONOGRAPH NOT FINAL part333A
0 2/0 1/20 17
LABELER -
JFL ENT ERPRISES, INC (010967011)
ESTABLISHMEN