MONK HAND SANITIZING WIPES- benzethonium chloride cloth 
National Towelette Company

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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Active Ingredients:
Benzethonium Chloride (0.3%)

Purpose:

Antibacterial

Use decreases bacteria on skin

Warnings For external use only

Do not use

When using this product

If contact occurs, rinse thoroughly with water

Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours

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

Directions: Adults and children 2 years and over: apply on hands and face to clean and refresh. Allow skin to dry without wiping. Children under 2 years: as a doctor before use. For Children under 6 use only under supervision.

Inactive Ingredients: Water, SD Alcohol 40-B, Sodium Benzoate, Diazolidinyl Urea, Glycerin, Propylene Glycol, Potassium Sorbate, Disodium EDTA, Tocopheryl Acetate, Aloe

Store under 110 F

Questions and Comments: For products or technical information, contact National Towelette Monday to Friday 8 AM to 4 PM EST at 1-800-738-9068, or visit our website at www.towelettes.com

MONK  HAND SANITIZING WIPES
benzethonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50320-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride30 mL  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R) 879 mL  in 1000 mL
Ethanol (UNII: 3K9958V90M) 111.60 mL  in 1000 mL
Sodium Benzoate (UNII: OJ245FE5EU) 1.30 mL  in 1000 mL
Diazolidinylurea (UNII: H5RIZ3MPW4) 1.30 mL  in 1000 mL
Glycerin (UNII: PDC6A3C0OX) 1.00 mL  in 1000 mL
Propylene Glycol (UNII: 6DC9Q167V3) 1.00 mL  in 1000 mL
Potassium Sorbate (UNII: 1VPU26JZZ4) .75 mL  in 1000 mL
Edetate Disodium (UNII: 7FLD91C86K) .45 mL  in 1000 mL
Alpha-Tocopherol Acetate (UNII: 9E8X80D2L0) 0.10 mL  in 1000 mL
Aloe (UNII: V5VD430YW9) 0.09 mL  in 1000 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50320-111-58500 mL in 1 CANISTER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33301/06/2010
Labeler - National Towelette Company (782795041)
Registrant - National Towelette Company (782795041)
Establishment
NameAddressID/FEIBusiness Operations
National Towelette Company782795041repack

Revised: 1/2010
Document Id: 9514da65-6c4b-4d24-a764-fdfac847680d
Set id: b4561258-852a-4247-b647-4d3c4f7eda2f
Version: 3
Effective Time: 20100106
 
National Towelette Company