HANDI SANI- alcohol liquid
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.

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Germ-X Hand Sanitizer
817

Active ingredient

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

•to decrease bacteria on the skin that could cause disease
•recommend 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 adult supervision
•not recommended for infants

Other information

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

Inactive ingredients

benzophenone-4, blue 1, carbomer, fragrance, glycerin, isopropyl alcohol, isopropyl myristate, propylene glycol, red 4, red 33, tocopheryl acetate, water

Distributed By: Vi-Jon
8515 Page Ave
St. Louis, MO 63114

principal display panel

Handi Sani
Hand Sanitizer
Germ-X
2 FL (59 mL)

image description

HANDI SANI
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11344-817
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	62 mL in 100 L

Ingredient Name	Strength
Inactive Ingredients
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)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
D&C RED NO. 33 (UNII: 9DBA0SBB0L)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11344-817-16	.059 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2012	10/12/2021
2	NDC:11344-817-18	.073 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2012	10/12/2021
3	NDC:11344-817-21	.089 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2012	10/12/2021
4	NDC:11344-817-34	.236 L in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/02/2012	10/12/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	04/02/2012	10/12/2021

Labeler - Vi-Jon, LLC (150931459)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11344-817)

Revised: 10/2021

Document Id: d81d4eb8-a21c-4753-a864-c7e78f0edc54

Set id: 4ee0e547-b848-462a-a30e-10be6f4720cc

Version: 8

Effective Time: 20211012

Vi-Jon, LLC

Germ-X Hand Sanitizer817