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NON ALCOHOL HAND SANITIZER

Dosage form: gel
Ingredients: Benzalkonium Chloride 0.1mL in 100mL
Labeler: Fercy Personal Care Products Co Limited
NDC Code: 50260-500

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.

Fercy Personal Care Products NON ALCOHOL HAND SANITIZER Lemon Flavor

Active IngredientBenzalkonium Chloride 0.1%

PURPOSEantiseptic

UseHand Cleanser reduces bacteria that could cause disease.

WarningKeep away from children.
For external use only.
Keep out of eyes,if contacts eyes,flush with water .call a doctor

DirectionsSpray a small amount in palm of hands,rapidly rub hands together until dry.
Do not store about 110 degree F(43 degree C)

Keep out of reach of childrenKeep out of reach of children

Inactive IngredientsDEIONIZED  WATER、GLYCERIN、PROPYLENE  GLYCOL、TRIETHANOLAMINE、CARBOMER、Lemon Flavor、Diazolidinyl Urea

NON ALCOHOL HAND SANITIZER 
benzalkonium chloride gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50260-500
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (Benzalkonium) Benzalkonium0.1 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER93.35 mL  in 100 mL
GLYCERIN2 mL  in 100 mL
PROPYLENE GLYCOL2 mL  in 100 mL
TROLAMINE1 mL  in 100 mL
CARBOMER 9340.9 mL  in 100 mL
Diazolidinyl Urea0.15 mL  in 100 mL
LEMON0.5 mL  in 100 mL
Product Characteristics
ColoryellowScore    
ShapeSize
FlavorLEMONImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:50260-500-012 mL in 1 BOTTLE, PLASTIC
2NDC:50260-500-025 mL in 1 BOTTLE, PLASTIC
3NDC:50260-500-038 mL in 1 BOTTLE, PLASTIC
4NDC:50260-500-0410 mL in 1 BOTTLE, PLASTIC
5NDC:50260-500-0515 mL in 1 BOTTLE, PLASTIC
6NDC:50260-500-0620 mL in 1 BOTTLE, PLASTIC
7NDC:50260-500-0730 mL in 1 BOTTLE, PLASTIC
8NDC:50260-500-0840 mL in 1 BOTTLE, PLASTIC
9NDC:50260-500-0950 mL in 1 BOTTLE, PLASTIC
10NDC:50260-500-1060 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/13/2010
Labeler - Fercy Personal Care Products Co Limited (529623870)
Establishment
NameAddressID/FEIOperations
Fercy Personal Care Products Co Limited529623870manufacture

Revised: 11/2010
Document Id: f8575e6b-5930-40de-bf98-0f141fc508c8
Set id: a8c5ec90-821a-4274-ac25-4aacc6e3419e
Version: 3
Effective Time: 20101125
 
Fercy Personal Care Products Co Limited

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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