ANTIBACTERIAL WET WIPES

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:

to decrease bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

HAND SANITIZER WATERMELLON- ALCOHOL SWAB
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 WET WIPES
ACTIVE INGREDIENT
Alcohol 65%
PURPOS E
Antiseptic Hand Sanitizer
US E
to decrease bacteria on the skin
WARNINGS
KEEP OUT OF REACH OF CHILDREN
if swallowed
get medical help or contact a Poison Control Center right away.
DIRECTIONS
Liberally spray on skin and gently massage until absorbed
INACTIVE INGREDIENT
Carbomer, Glycerin, Jojoba Particles, Pigment Blue 1, Propylene
Glycol, Triethanolamine, Water,
Watermellon Extract
HAND SANITIZER (ALCOHOL) SWAB
HAND SANITIZER WATERMELLON
alcohol swab
JFL ENTERPRISES, INC
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:71246 -30 0 4
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 5 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 )
TRO LAMINE (UNII: 9 O3K9 3S3TK)
PIGMENT RED 7 (UNII: 5Z5A8 9 AQ44)
JO JO BA ACID (UNII: MO7HV0 4S9 Y)
WATERMELO N (UNII: 231473QB6 R)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:71246 -30 0 4-1
30 mL in 1 POUCH; Type 0 : No t a Co mbinatio n Pro duct
0 2/0 2/20 17
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
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 RATIONS
Do ngguang Shuo guo Silico ne Pro du