TENSOGEL ANTISEPTIC HAND SANITIZER- ethyl alcohol 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 Hand Sanitizer Ethyl Alcohol

Active ingredient

Ethyl Alcohol 65%

Purpose

Antiseptic

Uses

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

Warnings

Flammable, keep away from fire or flame

For external use only

Do not use

in the eyes

Stop use and ask a doctor if

irritation and redness develop
if condition persists for more than 72 hours.

Keep out of reach of children.

If swallowed, get medical help or contacta Poison Control center right away.

Directions

wet hands thoroughly with product and allow to dry without wiping.

Other information

keep container in a well ventilated space

Inactive ingredients

Water, acrylic polymer, triethanolamine

Package Labeling

Label 000

TENSOGEL ANTISEPTIC HAND SANITIZER
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70821-000
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	650 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
TROLAMINE (UNII: 9O3K93S3TK)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70821-000-00	3800 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/10/2018	01/10/2018

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

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

Revised: 5/2021

Document Id: c1aa231e-291e-46e3-e053-2995a90ad370

Set id: 5c7809ad-e2e5-4091-82df-097cb6d640fd

Version: 2

Effective Time: 20210506

Biolimpieza de Centroamerica, S.A.