HANDI SANI

Main information

  • Trade name:
  • HANDI SANI- alcohol liquid
  • Composition:
  • ALCOHOL 62 mL in 100 L
  • Administration route:
  • TOPICAL
  • Prescription type:
  • OTC DRUG
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • HANDI SANI- alcohol liquid
    United States
  • Language:
  • English

Therapeutic information

  • Therapeutic indications:
  • •to decrease bacteria on the skin that could cause disease •recommend for repeated use

Status

  • Source:
  • DailyMed - NLM - National Library of Medicine
  • Authorization status:
  • OTC monograph not final
  • Authorization number:
  • 11344-961-16, 11344-961-18, 11344-961-21, 11344-961-34
  • Last update:
  • 02-06-2019

Summary of Product characteristics: dosage, interactions, side effects

HANDI SANI- alcohol liquid

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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Germ-X Handi Sani Hand Sanitizer

Active ingredient

Ethyl Alcohol 62%

Purpos e

Antiseptic

Us es

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 105 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 33, tocopheryl acetate, water

Distributed By: Vi-Jon

8515 Page Ave

St. Louis, MO 63114

Handi Sani

Hand Sanitizer

Germ-X

2 FL OZ (59 mL)

HANDI SANI

alcohol liquid

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:11344-9 6 1

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

6 2 mL in 10 0 L

Inactive Ingredients

Ingredient Name

Stre ng th

Vi-Jon

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

CARBO MER HO MO PO LYMER TYPE C ( ALLYL PENTAERYTHRITO L CRO SSLINKED) (UNII: 4Q9 3RCW27E)

GLYCERIN (UNII: PDC6 A3C0 OX)

ISO PRO PYL ALCO HO L (UNII: ND2M416 30 2)

ISO PRO PYL MYRISTATE (UNII: 0 RE8 K4LNJS)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

D&C RED NO . 3 3 (UNII: 9 DBA0 SBB0 L)

WATER (UNII: 0 59 QF0 KO0 R)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:11344-9 6 1-

.0 59 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 2/20 12

2

NDC:11344-9 6 1-

.0 73 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 2/20 12

3

NDC:11344-9 6 1-

.0 8 9 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 2/20 12

4

NDC:11344-9 6 1-

.236 L in 1 BOTTLE, PLASTIC; Type 0 : No t a Co mbinatio n

Pro duc t

0 4/0 2/20 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 4/0 2/20 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 (11344-9 6 1)

Revised: 12/2018