ADVANCED HAND SANITIZER- alcohol gel
Roundy's Supermarkets, 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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Roundys 370.001/370AE rev 1 Advanced Hand Sanitizer

Active Ingredient

Ethyl alcohol 70%

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 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

irritation or redness develops
condition 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 thoroghly with product and allow to dry without wiping
for children under 6, use only under adult supervision
not recommended for infants

Inactive ingredients

water, glyceryl caprylate/caprate, glycerin, isopropyl myristate, tocopheryl acetate, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, benzophenone-4

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

This product is not manufactured or distributed by GOJO Industries, Inc. distributor of Purell Refreshing Gel Advanced Hand Sanitizer.**

DISTRIBUTED BY ROUNDY'S SUPERMARKETS, INC.

MILWAUKEE, WI 53201-0473

Comments or Questions? 1-866-ROUNDYS

principal display panel

ROUNDY'S PERSONALS

ADVANCED HAND SANITIZER

More Effective Formula

Kills More Than 99.99% of Germs*

Compare to Purell Refreshing Gel**

Advanced Hand Santizer

8 FL OZ (236 mL)

image description

ADVANCED HAND SANITIZER
alcohol gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11150-370
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M)	ALCOHOL	70 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
water (UNII: 059QF0KO0R)
GLYCERYL CAPRYLATE/CAPRATE (UNII: G7515SW10N)
GLYCERIN (UNII: PDC6A3C0OX)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CARBOMER COPOLYMER TYPE b (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 809Y72KV36)
SULISOBENZONE (UNII: 1W6L629B4K)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11150-370-34	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/23/2015	11/02/2021

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/23/2015	11/02/2021

Labeler - Roundy's Supermarkets, Inc (007947195)

Registrant - Vi-Jon, LLC (790752542)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		088520668	manufacture(11150-370)

Name	Address	ID/FEI	Business Operations
Establishment
Vi-Jon, LLC		790752542	manufacture(11150-370)

Revised: 11/2021

Document Id: 6ff3c358-4df4-42ff-8b1e-8bbb39fca9b1

Set id: d88ed1c4-66b7-42b4-9047-d149f9a6a982

Version: 9

Effective Time: 20211102

Roundy's Supermarkets, Inc