Moisturizing Hand Sanitizer: Package Insert and Label Information

MOISTURIZING HAND SANITIZER- alcohol gel
Vi-Jon, LLC

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.

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 105
  • 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

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)

image description
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MOISTURIZING HAND SANITIZER
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-538
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Alcohol (ALCOHOL) Alcohol 558 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SULISOBENZONE
FD&C BLUE NO. 1
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)
GLYCERIN
ISOPROPYL ALCOHOL
ISOPROPYL MYRISTATE
.ALPHA.-TOCOPHEROL ACETATE
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11344-538-34 236 mL in 1 BOTTLE, PUMP None
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, LLC (790752542)
Registrant — Vi-Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi-Jon, LLC 088520668 manufacture (11344-538)

Revised: 05/2022 Vi-Jon, LLC

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