PRO-TEC® Hand Sanitizer70% Ethyl Alcohol

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Jefferson Labs. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- hand sanitizer liquid 
Jefferson Labs

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.

----------

PRO-TEC®
Hand Sanitizer
70% Ethyl Alcohol

Drug Facts

Active Ingredient

Ethyl Alcohol 70%

Purpose

Antiseptic

Uses

• to help reduce bacteria on the skin that could cause disease
• recommended for repeated use

Warnings

For external use only: hands

Flammable. Keep away from fire or flame.

When using this product 

• keep out of eyes. In case of contact with eyes, flush thoroughly with water.
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• irritation and redness develops
• 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

For 946 mL bottle

• use to refill a pump bottle. From the pump bottle apply a small amount onto hands, rub thoroughly with product and allow to dry without wiping
• do not use on children less than 2 months of age
• not recommended for infants

For 473 mL bottle

• wet hands thoroughly with product and allow to dry without wiping
• do not use on children less than 2 months of age
• not recommended for infants

Other Information

• store between 20–25° C (68–77° F). Avoid excessive heat above 40° C (104° F).
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

Citrate Buffer, Glycerin, Hydroxyethyl Cellulose, Isopropyl Alcohol, PEG, Water

MANUFACTURED BY:
Aurora Pharmaceutical, Inc.
NORTHFIELD, MINNESOTA 55057
888-215-1256

MADE IN THE USA

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

NDC: 51072-112-00

PRO-TEC®

Hand Sanitizer

70% Ethyl Alcohol

REFILL

32 fl. oz. (946 mL)

REORDER NO: 21025

IN 50-1661 02/2020

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

NDC: 51072-112-01

PRO-TEC®

Hand Sanitizer

70% Ethyl Alcohol

16 fl. oz. (473 mL)

REORDER NO: 21026

IN 50-1663 02/2020

HAND SANITIZER 
hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51072-112
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)
HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
ISOPROPYL ALCOHOL (UNII: ND2M416302)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-112-00	946 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/06/2020	05/31/2022
2	NDC: 51072-112-01	473 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/24/2020	05/31/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	04/06/2020	05/31/2022

Labeler - Jefferson Labs (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Jefferson Labs		832848639	manufacture(51072-112)

Revised: 8/2020

Document Id: e645a4c4-abbb-4117-ba51-0d1d2cecd46b

34390-5

Set id: 53739cfe-1b29-4e3d-95bf-ba1569413d3a

Version: 1

Effective Time: 20200804