HYDRATING INSTANT HAND SANITIZER- alcohol gel 
HANOVER PEN CORP dba HPC Global

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 Ingredient

Ethyl Alcohol 70 percent

Purpose

Antimicrobial

Uses

Cleansing gel for hands that need frequent care.

Decrease bacteria on skin.

Warnings

For external use only.

Flammable, keep away from fire or flame.

Do not use in or near the eyes, in case of exposure rinse eyes throughly with water.

Do not use if you have preexisting rash condition.

Stop use and ask a doctor if irritation, redness or rash appear.

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

Directions

Apply approximately 3ml on palm and rub hands for 30 seconds.

Rinsing is not required.

Inactive Ingredients

aloe barbadensis, aroma, blue 1 (CI 42090), carbomer, cetyl alcohol, glycerin, panthenol, tocopherol acetate, triethanolamine, water, yellow 5 (CI 19140)

Drug Facts

Monarch HS Pouch

HYDRATING INSTANT HAND SANITIZER 
alcohol gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-659
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL.6329 mL  in .9242 mL
Inactive Ingredients
Ingredient NameStrength
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
TROLAMINE (UNII: 9O3K93S3TK)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51811-659-00.9242 mL in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E02/01/2013
Labeler - HANOVER PEN CORP dba HPC Global (003022670)
Registrant - HANOVER PEN CORP dba HPC Global (003022670)
Establishment
NameAddressID/FEIBusiness Operations
HANOVER PEN CORP dba HPC Global003022670repack(51811-659) , label(51811-659)
Establishment
NameAddressID/FEIBusiness Operations
Micrylium Laboratories252529185manufacture(51811-659)

Revised: 2/2013
Document Id: e62b853f-85bf-4983-af77-6825dd5e5438
Set id: 59039203-eb42-4079-86e9-a4752e4d6f4a
Version: 1
Effective Time: 20130201
 
HANOVER PEN CORP dba HPC Global