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%

Purpose

Antiseptic

Use

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

Label 001

TENSOGEL ANTISEPTIC HANDWASH
triclosan gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70821-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X)	TRICLOSAN	1 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SODIUM LAURETH-5 SULFATE (UNII: 410Q7WN1BX)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
COCO MONOETHANOLAMIDE (UNII: C80684146D)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
DMDM HYDANTOIN (UNII: BYR0546TOW)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70821-001-00	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018	12/04/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	01/10/2018	12/04/2019

Labeler - Biolimpieza de Centroamerica, S. A. (816179388)

Revised: 1/2020

Document Id: 9bb83503-ad04-98b1-e053-2995a90ab8f2

Set id: 263a68f4-a601-45e4-afb5-066a477d6fdc

Version: 2

Effective Time: 20200109

Biolimpieza de Centroamerica, S. A.