PROFORMANCE ANTIBACTERIAL- triclosan liquid

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Pro-Link, Inc.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antibacterial For hand washing to reduce bacteria on the skin

Authorization status:

OTC monograph not final

Summary of Product characteristics

PROFORMANCE ANTIBACTERIAL- TRICLOSAN LIQUID
PRO-LINK, 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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DRUG FACTS
ACTIVE INGREDIENT
Triclosan, 0.30%
PURPOS E
Antibacterial
US ES
For hand washing to reduce bacteria on the skin
WARNINGS
For external use only
WHEN USING THIS PRODUCT
avoid contact with eyes. In case of eye contact, flush with water.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
Apply foaming cleanser to dry hands
Rub hands together to spread lather
Wash for 15-20 seconds
Rinse and dry hands thoroughly
INACTIVE INGREDIENTS
Water, Sodium Laureth Sulfate, Propylene Glycol, PEG-7 Glyceryl
Cocoate,
Glycerin, Cocamidopropyl Betaine, 2-Bromo-2-nitropropane-1,3-diol,
Fragrance, Citric Acid,
Methylchloroisothiazolinone, Methylisothiazolinone, Green 5 (CI
61570), Yellow 5 (CI 19140).
ProFormance Series
ProLink
Antibacterial Foam Soap
TA1200
Distributed exclusively By:
Pro-Link, Inc.
Canton, MA 02021
Ph.: 800-74-LINKS
www.
Rev. 07-13
1200 mL
40.6 Fluid Ounces
PROFORMANCE ANTIBACTERIAL
triclosan liquid
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:6 6 9 0 8 -532
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 .30 mg in 10 0 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM LAURETH SULFATE (UNII: BPV39 0 UAP0 )
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 QP)
D&C GREEN NO . 5 (UNII: 8 J6 RDU8 L9 X)
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
Pro-Link, Inc.
FD&C YELLO W NO . 5 (UNII: I753WB2F1M)
PEG-7 GLYCERYL CO CO ATE (UNII: VNX7251543)
GLYCERIN (UNII: PDC6 A3C0 OX)
METHYLCHLO RO ISO THIAZ