TCI Antiseptic Hand Sanitizer

TCI Antiseptic Hand Sanitizer by

Drug Labeling and Warnings

TCI Antiseptic Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Tetra-Chem Industries Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TCI ANTISEPTIC HAND SANITIZER- isopropyl alcohol liquid 
Tetra-Chem Industries 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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TCI Antiseptic Hand Sanitizer

Drug Facts

Active ingredient

Isopropyl alcohol 70% v/v

Purpose

Antiseptic

Uses

• hand sanitizer to decrease bacteria on the skin
• recommended for repeated use
• for use when soap and water are not available

Warnings

Flammable, keep away from fire/flame
For external use only

Do not use

• in children less than two months of age
• on open skin wounds

When using this product  do not get into eyes. In case of contact, rinse eyes thoroughly with water

Stop use and ask a doctor if

• irritation and redness develop
• condition persists 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

• wet hands thoroughly with product and allow to dry without wiping
• supervise children under 6 years of age when using this product to avoid swallowing

Other information

• store between 15–30°C (59–86°F)
• avoid freezing and excessive heat above 40°C (104°F)

Inactive ingredients

benzalkonium chloride, glycerin, hydroxymethyl cellulose, water

Questions?

+1-888-658-5515
You may also report serious side effects to this phone number.
Mon–Fri 9 AM–5 PM

View Product Application/SDS:

tetra-chem.com/sc/615

NPN: 80098195

This company assumes no responsibility or liability for personal injury or material destruction through improper handling or use of this product.
Please call our technical support line at 1‑888‑658‑5515

Manufactured by:
TCI Applied Science and Technology Inc.,
271 Ingersoll St. S., Ingersoll, Ontario, Canada N5C 3J7

Country of Origin: Canada

TEL: (519) 485-4370
TOLL FREE: (888) 658-5515
FAX: (855) 762-4446
WEB SITE: tetra-chem.com
EMAIL: info@tetra-chem.com

Packaging

TCI ANTISEPTIC HAND SANITIZER 
isopropyl alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81173-615
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	70 L  in 100 L

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYMETHYL CELLULOSE (UNII: 273FM27VK1)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81173-615-04	4 L in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2020	06/14/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/25/2020	06/14/2024

Labeler - Tetra-Chem Industries Ltd (247375157)

Establishment
Name	Address	ID/FEI	Business Operations
Tetra-Chem Industries Ltd		247375157	manufacture(81173-615)

Revised: 10/2021

Document Id: a21bacdd-f8a0-4907-aa14-3be10251c234

34390-5

Set id: cb291ea3-4375-433e-b893-ae924452b9bc

Version: 2

Effective Time: 20211011