OTC Medication Information: Hand Sanitizer

HAND SANITIZER- 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.

claims

germ-X

Professional

ORIGINAL

HAND SANITIZER

ACTIVE INGREDIENTS

Ethyl alcohol 63%

purpose

Antiseptic

use

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

warnings

For external use only: hands

Flammable, keep away from fire or 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

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

Keep out of reach of children.

If swallowed, get medical help or contact 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

acrylates/C10-30 alkyl acrylate crosspolymer, benzophenone-4, fragrance, glycerin, tocopherol, water

claims

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

adverse reactions

DISTRIBUTED BY: VI-JON, LLC

8515 Page Ave

ST. LOUIS, MO 63114

vijonprofessional.com

germ-X

Professional

ORIGINAL

HAND SANITIZER

kILLS 99.99% of Germs

With Vitamin E

128 FL OZ (1 GAL) 3.79 L

image description
(click image for full-size original)
HAND SANITIZER
alcohol liquid
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11344-437
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (ALCOHOL) ALCOHOL 63 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)
SULISOBENZONE
GLYCERIN
TOCOPHEROL
water
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11344-437-27 1150 mL in 1 BOTTLE, PLASTIC None
2 NDC:11344-437-86 1000 mL in 1 BOTTLE, PLASTIC None
3 NDC:11344-437-20 44 mL in 1 BOTTLE, PLASTIC None
4 NDC:11344-437-16 59 mL in 1 PACKAGE None
5 NDC:11344-437-18 73 mL in 1 BOTTLE, PLASTIC None
6 NDC:11344-437-21 88 mL in 1 BOTTLE, PLASTIC None
7 NDC:11344-437-26 118 mL in 1 BOTTLE, PLASTIC None
8 NDC:11344-437-63 200 mL in 1 BOTTLE, PLASTIC None
9 NDC:11344-437-34 236 mL in 1 BOTTLE, PLASTIC None
10 NDC:11344-437-38 295 mL in 1 BOTTLE, PLASTIC None
11 NDC:11344-437-32 354 mL in 1 BOTTLE, PLASTIC None
12 NDC:11344-437-49 443 mL in 1 BOTTLE, PLASTIC None
13 NDC:11344-437-04 750 mL in 1 BOTTLE, PLASTIC None
14 NDC:11344-437-42 828 mL in 1 PACKAGE None
15 NDC:11344-437-09 887 mL in 1 BOTTLE, PLASTIC None
16 NDC:11344-437-57 1656 mL in 1 BOTTLE, PLASTIC None
17 NDC:11344-437-68 1972 mL in 1 BOTTLE, PLASTIC None
18 NDC:11344-437-08 44 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 06/13/2016
Labeler — Vi-Jon, LLC (790752542)
Registrant — Vi Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon, LLC 790752542 manufacture (11344-437)

Revised: 05/2022 Vi-Jon, LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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