FDA.reportPublic FDA data

TENSOGEL Antiseptic Handwash

Manufacturer
Biolimpieza de Centroamerica, S. A.
Effective date
2018-01-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:04:45

Label at a glance#

ProductTENSOGEL Antiseptic Handwash
Active ingredientTRICLOSAN
Label structure7 sections

Dosage and administration

Apply a samll amount on your hands, wash and brush hands and nails properly until clean rinse with water.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Triclosan 0.1%

Purpose

OTC - PURPOSE SECTION

Antiseptic

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • on infants under 6 months of age

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation and refness develop and if condition presists for more than 72 hours.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply a samll amount on your hands, wash and brush hands and nails properly until clean
  • rinse with water.

Other information

SPL UNCLASSIFIED SECTION

  • store in a cool, dry place
  • do not expose to sunlight
  • keep container tightly closed after use

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, sodium laureth-5-sulfate, cocamide dea, sodium chloride, glycol distearate, cocamide mea, cocamidopropyl betaine, methylchloroisothiazolinone, methylisothiazolinone, dmdm hydantion

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 001Label 001

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70821-00170821-001-00

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM LAURETH-5 SULFATE410Q7WN1BXIACT
COCO DIETHANOLAMIDE92005F972DIACT
SODIUM CHLORIDE451W47IQ8XIACT
GLYCOL DISTEARATE13W7MDN21WIACT
COCO MONOETHANOLAMIDEC80684146DIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
DMDM HYDANTOINBYR0546TOWIACT
TRICLOSAN4NM5039Y5XACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
62e72690-48ab-7825-e053-2a91aa0af8f7263a68f4-a601-45e4-afb5-066a477d6fdc2018-01-16WarningsExact identifier
spl id: 62e72690-48ab-7825-e053-2a91aa0af8f7
spl set id: 263a68f4-a601-45e4-afb5-066a477d6fdc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.