TRUE ESSENTIALS HAND SANITIZER- benzalkonium chloride lotion 
Fortune Hi-Tech

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:........................Purpose:

Benzalkonium Chloride 0.1%........................Antiseptic

Use:

Warnings:

For external use only--skin.

Flammable.

Keep away from heat and flame.

When using this product

Stop use and ask a doctor if

skin irritation develops.

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Directions

Other information

Inactive ingredients

Water, Pentylene Glycol, Dimethicone, Glyceryl Laurate, Distearyldimonium Chloride, Cetyl Alcohol, Glycerin, Tocopheryl (Vitamin E) Acetate, Allantoin, Tetrasodium EDTA, Blue 1, Yellow 5, Fragrance

Questions?

Call 1-859-422-7048

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TRUE ESSENTIALS  HAND SANITIZER
benzalkonium chloride lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24488-006
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE.59 mL  in 59 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
GLYCERYL LAURATE (UNII: Y98611C087)  
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ALLANTOIN (UNII: 344S277G0Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24488-006-2359 mL in 1 VIAL, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333E04/13/2011
Labeler - Fortune Hi-Tech (961956229)
Registrant - Creations Garden Natural Products (961956229)
Establishment
NameAddressID/FEIBusiness Operations
Creations Garden Natural Products961956229manufacture

Revised: 4/2011
Document Id: 321b53ad-4717-40be-ade0-2687c4ddf253
Set id: 1ce27326-2629-4173-b0f9-406f909a2c0d
Version: 1
Effective Time: 20110413
 
Fortune Hi-Tech