HAND SANITIZER- isopropyl alcohol gel

Hand sanitizer by

Drug Labeling and Warnings

Hand sanitizer by is a Otc medication manufactured, distributed, or labeled by INOVAKER LAB S.A. DE C.V., INOVAKER LAB S.A. DE C.V. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Directions

Place enough product on hands to cover all surfaces. Rub hands together until dry.

Supervise children under 6 years of age when using this product to avoid swallowing

Warnings

For external use only. Flammable. Keep away from heat of flame

Inactive ingredients

Water (aqua), glycerin, triethanolamine, carbomer, fragrance.

Use(s)

Health care personnel hand rub to help reduce bacteria that potentially can cause disease.

KEEP OUT OF REACH OF CHILDREN

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

Purpose

Hand sanitizer. Antiseptic

Active ingredient

Isopropyl alcohol 75% v/v

Do not use

In children less than 2 months of age.

On open skin wounds.

When using this product

Keep out eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water

PRINCIPAL DISPLAY PANEL

60 mL NDC: 77271-001-01

PRINCIPAL DISPLAY PANEL

250 mL NDC: 77271-001-02

PRINCIPAL DISPLAY PANEL

500 mL NDC: 77271-001-03

PRINCIPAL DISPLAY PANEL

750 mL 77271-001-04

PRINCIPAL DISPLAY PANEL

1000 mL NDC: 77271-001-05

PRINCIPAL DISPLAY PANEL

4000 mL NDC: 77271-001-06

PRINCIPAL DISPLAY PANEL

120ml NDC: 77271-001-01

INGREDIENTS AND APPEARANCE

HAND SANITIZER 
isopropyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77271-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302)	ISOPROPYL ALCOHOL	75 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	21.5 mL  in 100 mL
POLYACRYLIC ACID (8000 MW) (UNII: 73861X4K5F)	0.5 mL  in 100 mL
TROLAMINE (UNII: 9O3K93S3TK)	0.2 mL  in 100 mL
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK)	0.4 mL  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX)	1 mL  in 100 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77271-001-01	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
2	NDC: 77271-001-02	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
3	NDC: 77271-001-03	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
4	NDC: 77271-001-04	750 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
5	NDC: 77271-001-05	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020
6	NDC: 77271-001-06	4000 mL in 1 BOTTLE; Type 0: Not a Combination Product	05/11/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/11/2020

Labeler - INOVAKER LAB S.A. DE C.V. (951577122)

Registrant - INOVAKER LAB S.A. DE C.V. (951577122)

Establishment
Name	Address	ID/FEI	Business Operations
INOVAKER LAB S.A. DE C.V		951577122	manufacture(77271-001)