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Fresh N Up

Dosage form: solution
Ingredients: BENZALKONIUM CHLORIDE 0.115mL in 100mL
Labeler: Rockline Industries, Inc
NDC Code: 57624-601

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.

Drug Facts

Active Ingredient

Benzalkonium chloride 0.115%

Purpose

Antibacterial

UsesFor hand washing to decrease bacteria on the skin

Warnings For external use only

When using this productavoid the eyes and mucous membranes
If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor ifif irritation develops and persists for more than 72 hours.

Keep out of reach of children

Keep out of reach of children. If swallowed contact a doctor or Poison Control Center right away.

Other InformationMay be used on face, arms and legs.

Directions
  • For use apply thoroughly to hands and face as desired. Allow to dry without wiping. Discard wipe in trash receptacle after use. Do not flush.
  • For dispensing tear open package at notch. Dispose of wrapper in trash. Do  not flush

Inactive IngredientsAcrylates Copolymer, Benzophenone-4, Citric Acid, Cocamide DEA, Cocamidopropyl Betaine, Disodium EDTA, FDC Yellow 5, FDC Blue 1, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Chloride, Sodium Laureth Sulfate, Water

Package LabelPackage label



FRESH N UP 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57624-601
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (BENZALKONIUM) BENZALKONIUM CHLORIDE0.115 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
ALOE VERA LEAF 
METHYLCHLOROISOTHIAZOLINONE 
METHYLISOTHIAZOLINONE 
EDETATE DISODIUM 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage Description
1NDC:57624-601-150.115 mL in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A10/01/2010
Labeler - Rockline Industries, Inc (066886102)
Establishment
NameAddressID/FEIOperations
Hgiene Salud, S.A. de C.V.814608832manufacture

Revised: 09/2010
Document Id: 993d22e0-2d01-4c91-baef-fb4f0eded888
Set id: f886b704-0a6a-4bc3-8bfd-d97996eb25d0
Version: 1
Effective Time: 20100921
 
Rockline Industries, Inc

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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