SKINTEGRITY ANTIBACTERIAL HAND CLEAR triclosan soap

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)

Available from:

Medline Industries, Inc.

INN (International Name):

TRICLOSAN

Composition:

TRICLOSAN 0.5 mg in 100 mL

Prescription type:

OTC DRUG

Authorization status:

OTC monograph not final

Summary of Product characteristics

SKINTEGRITY ANTIBACTERIAL HAND CLEAR- TRICLOSAN SOAP
MEDLINE INDUSTRIES, 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._
----------
DRUG FACTS
ACTIVE INGREDIENT
Triclosan 0.5%
PURPOS E
Antiseptic Handwash
US ES
for handwashing to decrease bacteria on the skin
WARNINGS
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
avoid contact with eyes. In case of eye contact, immediately flush
with water.
STOP USE AND ASK A DOCTOR IF
irritation or redness develop
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 wet hands
lather vigorously for at least 15 seconds
rinse and dry thoroughly
INACTIVE INGREDIENTS
Water, Ammonium Lauryl Sulfate, Sodium Laureth Sulfate, Sodium
Chloride, Cocamide DEA,
Disodium Cocamido MIPA-Sulfosuccinate, Glycerin, Polyquaternium-7,
DMDM Hydantoin, BHT,
Fragrance, Citric Acid, Tetrasodium EDTA, Glutamic Acid, Leucine,
Serine, Phenylalanine, Proline,
Glycine, Valine, Isoleucine, Arginine, Citric Acid, Yellow 5, Red 33.
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
MEDLINE
NDC 53329-019-84
S KINTEGRITY
ANTIBACTERIAL HAND SOAP
33.8 fl oz (1000 mL)
SKINTEGRITY ANTIBACTERIAL HAND CLEAR
triclosan soap
PRODUCT INFORMATION
Medline Industries, Inc.
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:53329 -0 19
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)
TRICLOSAN
0 .5 mg in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
AMMO NIUM LAURYL SULFATE (UNII: Q7AO2R1M0 B)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)
GLYCERIN (UNII: PDC6 A3C0 OX)
PO LYQ UATERNIUM-7 ( 7 0 /3 0 ACRYLAMIDE/DADMAC;