Germ-X by Vi Jon, LLC GERM-X- alcohol liquid

Germ-X by

Drug Labeling and Warnings

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

Drug Details [pdf]

claims

Introducing the most efective Germ-X formula ever

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

Active ingredient

Ethyl Alcohol 70%

purpose

Antiseptic

Use

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

Warnings

For exterenal 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 thoroghly with water.
• avoid contact with broken skin
• do not inhale or ingest

Stop use and ask a doctor if

• irritation or redness develops
• condition pereists for more than 72 hours

Keep out of reach of children.

If swallowed, get medical help or contract a Poison Control Cener 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 105⁰F
• may discolor some fabrics
• harmful to wood finishes and plastics

inactive ingredients

water, Aloe barbadensis leaf juice, glyceryl capryate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4, yellow 5, blue 1

Adverse Reactions Section

Distributed By

Vi-Jon, Inc.

8515 Page Ave.

St. Louis, MO 63114

www/germx.com

766.000/766AA

principal display panel

germ-x

ADVANCED

Hand Sanitizer

MORE EFFECTIVE FORMULA

kills more than 99.99% of germs

PATENTED FORMULA

Aloe

33.8 FL OZ (1L)

INGREDIENTS AND APPEARANCE

GERM-X 
alcohol liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-766
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	616 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
SULISOBENZONE (UNII: 1W6L629B4K)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-766-34	237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/21/2017
2	NDC: 11344-766-86	1000 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	08/21/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	08/21/2017

Labeler - Vi Jon, Inc (150931459)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		150931459	manufacture(11344-766)