HAND SANITIZER- ethyl alcohol gel

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)
Available from:
Vi-Jon
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Antiseptic Uses - for handwashing to decrease bacteria on the skin - recommended for repeated use skin irritation develops
Authorization status:
OTC monograph not final
Authorization number:
11344-410-34

HAND SANITIZER- ethyl alcohol gel

Vi-Jon

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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Drug Facts

Claims

Germ-X

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

Active Ingredient

Ethyl Alcohol 65%

Purpos e

Antiseptic

Us e

Us es

for handwashing to decrease bacteria on the skin

recommended for repeated use

Warnings

For external use only-hands

Flammable

Flammable. Keep away from heat and flame.

When using this product

keep out of eyes. In case of contct with eyes, flush thoroughly with water.

avoid contact with broken skin

do not inhale or ingest

Stop use

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 F

may discolor some fabrics

harmful to wood finishes and plastics

Inactive ingredients

benzophene-4, blue1, carbomer, cellulose, fragrance, glycerin, hydroxypropyl methylcellose, mannitol,

retinyl palmitate, tocopheryl acetate, ultramarines, water, yellow 5

Adverse reactions

Distributed By: Vi-Jon

8515 Page Ave

St. Louis, MO 63114

www.germx.com

principal display panel

germ-X

HAND SANITIZER

Cucumber Melon

KILLS 99.99% OF GERMS

8 FL OZ (236 mL)

HAND SANITIZER

ethyl alcohol gel

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11344-410

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ALCO HO L (UNII: 3K9 9 58 V9 0 M) (ALCOHOL - UNII:3K9 9 58 V9 0 M)

ALCOHOL

58 5 mg in 1 mL

Inactive Ingredients

Ingredient Name

Stre ng th

SULISO BENZO NE (UNII: 1W6 L6 29 B4K)

FD&C BLUE NO . 1 (UNII: H3R47K3TBD)

CARBO MER INTERPO LYMER TYPE A ( ALLYL SUCRO SE CRO SSLINKED) (UNII: 59 TL3WG5CO)

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

Vi-Jon

PO WDERED CELLULO SE (UNII: SMD1X3XO9 M)

GLYCERIN (UNII: PDC6 A3C0 OX)

HYPRO MELLO SES (UNII: 3NXW29 V3WO)

MANNITO L (UNII: 3OWL53L36 A)

VITAMIN A PALMITATE (UNII: 1D1K0 N0 VVC)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

ULTRAMARINE BLUE (UNII: I39 WR9 9 8 BI)

WATER (UNII: 0 59 QF0 KO0 R)

FD&C YELLO W NO . 5 (UNII: I753WB2F1M)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:11344-410 -

236 mL in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n

Pro duc t

0 1/30 /20 12

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt333A

0 1/30 /20 12

Labeler -

Vi-Jon (150931459)

Registrant -

Vi-Jon (790752542)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Vi-Jo n

0 8 8 520 6 6 8

ma nufa c ture (11344-410 )

Revised: 5/2019

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