FRESH N UP- benzalkonium chloride solution

Fresh N Up by

Drug Labeling and Warnings

Fresh N Up by is a Otc medication manufactured, distributed, or labeled by Rockline Industries, Inc, Hgiene Salud, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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 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

INGREDIENTS AND APPEARANCE

FRESH N UP 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57624-601
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.115 mL  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57624-601-15	0.115 mL in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/01/2010

Labeler - Rockline Industries, Inc (066886102)

Establishment
Name	Address	ID/FEI	Business Operations
Hgiene Salud, S.A. de C.V.		814608832	manufacture