ANTIBACTERIAL PROTECTIVE HAND- chlorhexidine gluconate lotion 
Hanover Pen Corp dba HPC Global

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Drug Facts

Active Ingredient

Chlorhexidine Gluconate 0.5%

Purpose

Antiseptic

Uses

Decrease bacteria on skin.

Recommended for repeated use.

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

Rub onto hands, as needed.

Inactive Ingredients

aloe barbadensis, aroma, carthamus tinctorius (safflower oleosomes), cellulose gum, cetyl alcohol, glycerin, glycerol stearate, panthenol, pvp, red 40 (ci 16035), tocopherol acetate, water, yellow 5 (CI 19140)

Drug Facts

MonarchHLPouch

ANTIBACTERIAL PROTECTIVE HAND 
chlorhexidine gluconate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51811-658
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE.0045 g  in .9 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA FLOWER (UNII: 575DY8C1ER)  
CARTHAMUS TINCTORIUS (SAFFLOWER) OLEOSOMES (UNII: 9S60Q72309)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PANTHENOL (UNII: WV9CM0O67Z)  
POVIDONE K30 (UNII: U725QWY32X)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
WATER (UNII: 059QF0KO0R)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51811-658-00.9 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/01/2013
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(51811-658) , label(51811-658)
Establishment
NameAddressID/FEIBusiness Operations
Micrylium Laboratories252529185manufacture(51811-658)

Revised: 2/2013
Document Id: db32639b-8fd0-4078-b3c6-ae9485f7f5f6
Set id: 25f64ae2-fc3a-4fc5-b659-98cb5c6fa199
Version: 1
Effective Time: 20130201
 
Hanover Pen Corp dba HPC Global