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NDC 81173-0635-04 Vital gel Antiseptic Hand Sanitizer 74 L/100L Details

Vital gel Antiseptic Hand Sanitizer 74 L/100L

Vital gel Antiseptic Hand Sanitizer is a TOPICAL GEL 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	81173-0635
Product ID	81173-635_26f7cc32-a79e-4f58-855f-49bd3fb30ddc
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	Vital gel Antiseptic Hand Sanitizer
Proprietary Name Suffix	n/a
Non-Proprietary Name	Isopropyl alcohol
Product Type	HUMAN OTC DRUG
Dosage Form	GEL
Route	TOPICAL
Active Ingredient Strength	74
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 81173-0635-04 (81173063504)

Pricing Information	N/A
NDC Package Code	81173-635-04
Billing NDC	81173063504
Package	4 L in 1 BOTTLE (81173-635-04)
Marketing Start Date	2020-11-25
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6b27c2dd-b899-4e19-b201-8825cd1229c8 Details

Drug Facts

Active ingredient

Isopropyl alcohol 74% 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, carbomer 940, glycerin, tetrahydroxypropyl ethylenediamine, 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/635

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

VITAL GEL ANTISEPTIC HAND SANITIZER

isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81173-635
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	74 L in 100 L

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
EDETOL (UNII: Q4R969U9FR)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:81173-635-04	4 L in 1 BOTTLE; Type 0: Not a Combination Product	11/25/2020	04/29/2024

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	11/25/2020	04/29/2024

Labeler - Tetra-Chem Industries Ltd (247375157)

Name	Address	ID/FEI	Business Operations
Establishment
Tetra-Chem Industries Ltd		247375157	manufacture(81173-635)

Revised: 10/2021

Document Id: 26f7cc32-a79e-4f58-855f-49bd3fb30ddc

Set id: 6b27c2dd-b899-4e19-b201-8825cd1229c8

Version: 2

Effective Time: 20211011