ATHLETICARE ANTI-BACTERIAL HAND AC 550- triclosan gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Petra Hygienic Systems Int Ltd

INN (International Name):

TRICLOSAN

Composition:

TRICLOSAN 2.5 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- For hand washing to decrease bacteria on the skin.

Authorization status:

OTC monograph not final

Summary of Product characteristics

ATHLETICARE ANTI-BACTERIAL HAND AC 550- TRICLOSAN GEL
PETRA HYGIENIC SYSTEMS INT 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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ATHLETICARE ANTI-BACTERIAL HAND SOAP AC 550
_DRUG FACTS_
_ACTIVE INGREDIENT_
Triclosan 0.25%
_PURPOSE_
Antibacterial
_USES_
- 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. Discontinue use and consult a
health practitioner if irritations develop.
KEEP OUT OF REACH OF CHILDREN.
If swallowed get medical help or contact a Poison Control Center right
away.
_DIRECTIONS_
Pump product into hands, lather vigorously for 15 seconds, rinse. Use
as part of your daily cleansing
routine.
_INACTIVE INGREDIENTS_
Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine,
Propylene Glycol, Disodium
EDTA, Hydroexyethyl Cellulose, Guar Hydroxypropyltrimonium
Chloride, Methylchloroisothiazolinone, Allantoin, Fragrance, Red 4.
PACKAGE LABELING:
ATHLETICARE ANTI-BACTERIAL HAND AC 550
triclosan gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:42326 -550
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
2.5 mg in 1 mL
INACTIVE INGREDIENTS
Petra Hygienic Systems Int Ltd
INGREDIENT NAME
STRE NG TH
PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)
ALLANTO IN (UNII: 344S277G0 Z)
FD&C RED NO . 4 (UNII: X3W0 AM1JLX)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM C14 -16 O LEFIN SULFO NATE (UNII: O9 W3D3YF5U)
PACKAG ING
#
ITEM CODE
PACKAGE DESCRIPTION
MARKETING START
DATE
MARKETING END
DATE
1
NDC:42326 -550 -
0 1
1 in 1 CARTON
0 3/0 5/20