FRESH N UP - benzalkonium chloride solution 
Rockline Industries, Inc

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

Benzalkonium chloride 0.115%

Purpose

Antibacterial

Uses

For hand washing to decrease bacteria on the skin

Warnings

For external use only

When using this product

avoid the eyes and mucous membranes
If contact occurs, rinse eyes thoroughly with water

Stop use and ask a doctor if

if 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 Information

May be used on face, arms and legs.

Directions

Inactive Ingredients

Acrylates 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 Label

Package label
image of package label



FRESH N UP 
benzalkonium chloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57624-601
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.115 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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/FEIBusiness Operations
Hgiene Salud, S.A. de C.V.814608832manufacture

Revised: 9/2010
Document Id: 993d22e0-2d01-4c91-baef-fb4f0eded888
Set id: f886b704-0a6a-4bc3-8bfd-d97996eb25d0
Version: 1
Effective Time: 20100921
 
Rockline Industries, Inc