ANTIBACTERIAL- chloroxylenol soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q)

Available from:

Seatex Ltd

INN (International Name):

CHLOROXYLENOL

Composition:

CHLOROXYLENOL 40 g in 1 kg

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

ANTIBACTERIAL - CHLOROXYLENOL SOAP
SEATEX LTD
_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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ANTI BACTERIAL LIQUID HAND SOAP
DRUG FACTS
ACTIVE INGREDIENT................PURPOSE
Chloroxylenol 0.40%................Antimicrobial
US ES
For hand washing to decrease bacteria on the skin.
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT avoid contact with eyes. In case of eye
contact, flush eyes with water.
STOP USE AND ASK A DOCTOR if irritation or redness develops, or if
condition persists for more than 72
hours.
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison Control Center right
away.
DIRECTIONS
Pump into hands, wet as needed.
Lather vigorously for at least 15 seconds
Wash skin, rinse thoroughly and dry.
INACTIVE INGREDIENTS
WATER, SODIUM LAURETH SULFATE,LAURYL GLUCOSIDE,COCAMIDOPROPYL BETAINE,
PROPYLENE GLYCOL,COCO GLUCOSIDE,GLYCERYL MONOOLEATE,SODIUM
CHLORIDE,DMDM HYDANTOIN,FD and C BLUE # 1
Manufactured by Seatex Ltd, Rosenberg,Texas 77471
label
ANTIBACTERIAL
chloroxylenol soap
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:76 250 -119 5
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
CHLO RO XYLENO L (UNII: 0 F32U78 V2Q) (CHLOROXYLENOL - UNII:0 F32U78
V2Q)
CHLOROXYLENOL
40 g in 1 kg
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
LAURYL GLUCO SIDE (UNII: 76 LN7P7UCU)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
CO CO GLUCO SIDE (UNII: ICS79 0 225B)
GLYCERYL MO NO O LEATE (UNII: 4PC0 54V79 P)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
DMDM HYDANTO IN (UNII: BYR0 546 TOW)
FD&C BLUE NO . 1 (UNII: H3R47K3TBD)
Seatex Ltd
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START DATE
MARKETING END DATE
1
NDC:76 2