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NDC 81173-0615-04 TCI Antiseptic Hand Sanitizer 70 L/100L Details

TCI Antiseptic Hand Sanitizer 70 L/100L

TCI Antiseptic Hand Sanitizer is a TOPICAL LIQUID in the HUMAN OTC DRUG category. It is labeled and distributed by Tetra-Chem Industries Ltd. The primary component is ISOPROPYL ALCOHOL.

Product Information

NDC	81173-0615
Product ID	81173-615_a21bacdd-f8a0-4907-aa14-3be10251c234
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	TCI Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	LIQUID
Route	TOPICAL
Active Ingredient Strength	70
Active Ingredient Units	L/100L
Substance Name	ISOPROPYL ALCOHOL
Labeler Name	Tetra-Chem Industries Ltd
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part333A
Listing Certified Through	n/a

Package

Package Images

NDC 81173-0615-04 (81173061504)

Pricing Information	N/A
NDC Package Code	81173-615-04
Billing NDC	81173061504
Package	4 L in 1 BOTTLE (81173-615-04)
Marketing Start Date	2020-11-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL cb291ea3-4375-433e-b893-ae924452b9bc Details

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

SPL UNCLASSIFIED SECTION

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: [email protected]

Packaging

INGREDIENTS AND APPEARANCE

TCI ANTISEPTIC HAND SANITIZER

isopropyl alcohol liquid

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

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

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

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

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

Labeler - Tetra-Chem Industries Ltd (247375157)

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

Revised: 10/2021

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

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

Version: 2

Effective Time: 20211011