Advanced Hand Sanitizer with Aloe

Advanced Hand Sanitizer with Aloe

Drug Labeling and Warnings

Drug Details

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ADVANCED HAND SANITIZER- ethyl alcohol gel 
Vi-Jon, Inc.

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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Advanced Hand Sanitizer with Aloe

Active ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• 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 and redness develop
• conditon persists for more than 72 hours

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 105⁰ F
• may discolor some fabrics
• harmful to wood finishes and plastics

Inactive ingredients

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

disclaimer

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

This product is not manufactu4red or distributed by GOJO industries, Inc. distributor of Purell Refreshing Aloe Advanced Hand Sanitizer

Distributed by: Vi-Jon, St. Louis, MO 63114

Alternate principal display panel - Mountain Falls Brand

Mountain falls

*Compare to Purell

With aloe & vitamin E

Kills more than 99.99% of germs**

Refreshes and moisturizes and softens hands mm01.jpg

Fast and effective

with aloe

Made in the USA with US and foreign parts

8 FL OZ (236 mL)

Swan

Advanced Hand Sanitizer

More effective formula

Kills more than 99.99% of germs*

Compare to Purell**

8 FL OZ (236 mL)

Alternate Principal Display Panel

SIMPLY U

ADVANCED

HAND

SANITIZER

ALOE SCENT

kills more than 99.99% of germs*

**Compare to Purell Refreshing Aloe Advanced Hand Sanitizer

32 FL OZ (946 mL)

ADVANCED HAND SANITIZER 
ethyl alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11344-439
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	700 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 BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11344-439-16	59 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product	07/26/2012
2	NDC: 11344-439-34	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/26/2012
3	NDC: 11344-439-49	443 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/26/2012
4	NDC: 11344-439-45	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	07/26/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/26/2012

Labeler - Vi-Jon, Inc. (150931459)

Registrant - Vi-Jon, Inc. (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi-Jon, Inc.		088520668	manufacture(11344-439)

Revised: 8/2018

Document Id: 7aefa6d2-3d6e-4860-bc8d-196ab8a39282

34390-5

Set id: 34d8a704-d7ef-4b8c-bb17-93367c1d558f

Version: 3

Effective Time: 20180830

 

Vi-Jon, Inc.