HAND SANITIZER- alcohol gel 
DOLGENCORP, 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.

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Drug Facts

Active ingredients

Active ingredient

Ethyl alcohol 65%

Purpose

Purpose

Antispetic

Use

Use

Warnings

Warnings

For external use only-hands

flammable

Flammable. Keep away from heat and flame

When using this product

When using this product

Stop use

Stop use and ask a doctor if skin irritation develops

Keep out of reach of children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Directions

Inactive ingredients

Inactive ingredients aloe barbadensis leaf juice, benzophenone-4, blue 1, carbomer, fragrance, glycerin, isopropyl myristate, propylene glycol, red 33, tocopheryl acetate, water

other information

Other information:

claims

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

MADE IN U.S.A. WITH U.S. AND FOREIGN COMPONENTS

Adverse reactions section

DISTRIBUTED BY DOLGENCORP, LLC

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072

Principal Display Panel

DG health

Instant

Hand

Sanitizer

with Lavender

+ Chamomile

8 FL OZ (236 mL)

image description

HAND SANITIZER 
ethyl alcohol gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-523
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL 650 mL  in 1 mL
Inactive Ingredients
Ingredient Name Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SULISOBENZONE (UNII: 1W6L629B4K)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
GLYCERIN (UNII: PDC6A3C0OX)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55910-523-34 236 mL in 1 BOTTLE, PUMP
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 08/19/2010
Labeler - DOLGENCORP, LLC (068331990)
Registrant - Vi-Jon (790752542)
Establishment
Name Address ID/FEI Business Operations
Vi-Jon 088520668 manufacture(55910-523)

Revised: 11/2012
Document Id: 9d03e7a2-8fec-485e-b962-dcef4b493cab
Set id: d47e457b-1676-41ae-91c6-36bb41e1290f
Version: 1
Effective Time: 20121107
 
DOLGENCORP, LLC