TENSOGEL ANTISEPTIC HANDWASH- triclosan gel

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Biolimpieza de Centroamerica, S. A.

INN (International Name):

TRICLOSAN

Composition:

TRICLOSAN 1 mg in 1 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

- for hand washing to decrease bacteria on the skin - recommended for repeated use.

Authorization status:

OTC monograph not final

Summary of Product characteristics

TENSOGEL ANTISEPTIC HANDWASH- TRICLOSAN GEL
BIOLIMPIEZA DE CENTROAMERICA, S. A.
_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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TENSOGEL ANTISEPTIC HANDWASH TRICLOSAN
ACTIVE INGREDIENT
Triclosan 0.1%
PURPOS E
Antiseptic
US E
for hand washing to decrease bacteria on the skin
recommended for repeated use.
WARNINGS
For external use only
DO NOT USE
in the eyes
on infants under 6 months of age
STOP USE AND ASK A DOCTOR IF
irritation and refness develop and if condition presists 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
Apply a samll amount on your hands, wash and brush hands and nails
properly until clean
rinse with water.
OTHER INFORMATION
store in a cool, dry place
do not expose to sunlight
keep container tightly closed after use
INACTIVE INGREDIENTS
Water, sodium laureth-5-sulfate, cocamide dea, sodium chloride, glycol
distearate, cocamide mea,
cocamidopropyl betaine, methylchloroisothiazolinone,
methylisothiazolinone, dmdm hydantion
PACKAGE LABELING
TENSOGEL ANTISEPTIC HANDWASH
triclosan gel
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:70 8 21-0 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
Biolimpieza de Centroamerica, S. A.
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
TRICLO SAN (UNII: 4NM50 39 Y5X) (TRICLOSAN - UNII:4NM50 39 Y5X)
TRICLOSAN
1 mg in 1 mL
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
SO DIUM LAURETH-5 SULFATE (UNII: 410 Q7WN1BX)
CO CO DIETHANO LAMIDE (UNII: 9 20 0 5F9 72D)
SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)
GLYCO L DISTEARATE (UNII: 13W7MDN21W)
CO CO MO NO ETHANO LAMIDE (UNII: C8 0 6 8 4146 D)
CO CAMIDO PRO PYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)
METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)
DMDM HYDANTO