MOISTURIZING HAND SANITIZER- ethyl alcohol gel

Moisturizing Hand Sanitizer by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

Gem-X

KILLS GERMS IN 15 SECONDS

Effective at eliminating 99.99% of many common harmful germs & bacteria in as little as 15 seconds.

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Use

• For handwashing to decrease bacteria on the skin
• Recommended for repeated use

Warnings

For external use only: hands

Flammable

Keep away from heat and 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 skin irritation develops

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
• for children under 6, use only under adult supervision
• not recommended for infants

Other information

• do not store above 105⁰
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

benzophenone-4, blue 1, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, tocopheryl acetate, water

Adverse Reactions 

Distributed By

Vi-Jon

8515 Page Ave

St. Louis, MO 63114

www.germx.com

538.001/538AD

principal display panel

germ-X

moisturizing

island wind

hand sanitizer

KILLS GERMS IN 15 SECONDS

KILLS 99.99% OF GERMS

8 FL OZ (236 mL)

INGREDIENTS AND APPEARANCE

MOISTURIZING HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-538
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	Alcohol	558 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-538-34	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	01/05/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	01/05/2009

Labeler - Vi-Jon (150931459)

Registrant - Vi-Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon		088520668	manufacture(11344-538)