Hand Sanitizer by Medline Industries, Inc. / Vi-Jon, LLC 001 UMC Hand Sanitizer

Hand Sanitizer by

Drug Labeling and Warnings

Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Medline Industries, Inc., Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

HAND SANITIZER- alcohol liquid 
Medline Industries, Inc.

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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001 UMC Hand Sanitizer

Active ingredient

Ethyl alcohol 62%

purpose

Antiseptic

Use

• to decrease 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 or redness develops
• condition persists for more than 72 hours

Keep out of reach 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
• for children under 6, use only under adult suervision
• not recommended for infants

Other information

• do not store above 105° F
• may discolor some fabrics
• harmful to wood finishes and plastics

inactive ingredients

water, Aloe barbadensis leaf juice, tocopheryl acetate, glycerin, isopropyl myristate, propylene glycol, carbomer, diisopropylamine

adverse reactions

REF HH62G02UMC

www.medline.com

Made in USA with US and Foreign components

for Medline industries, Inc.,

Northfield, IL 60093 USA

1-800-MEDLINE  RG17VJO

495.001/495AA Rev 1

principal display panel

UMC

UNIVERSITY MEDICAL CENTER

Hand

Sanitizer

62% Ethyl

ALCOHOL

Kills 99.99% of germs

Moisturizing & Vitamin E

Gentle enough

for repeated use

2 FL OZ (59 mL)

HAND SANITIZER 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
DIISOPROPYLAMINE (UNII: BR9JLI40NO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-001-13	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	08/16/2017	03/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/16/2017	03/01/2018

Labeler - Medline Industries, Inc. (025460908)

Registrant - Vi-Jon, Inc (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc		088520668	manufacture(53329-001)

Revised: 12/2019

Document Id: 9ab0d58f-834e-7f0f-e053-2a95a90aaa40

34390-5

Set id: 000aecdc-d965-469d-a97d-e7b5c18442db

Version: 4

Effective Time: 20191227

 

Medline Industries, Inc.