FRESH N UP- benzalkonium chloride solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

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SPC SPC (SPC)
21-09-2010

active_ingredient:

BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)

MAH:

Rockline Industries, Inc

INN:

BENZALKONIUM CHLORIDE

composition:

BENZALKONIUM CHLORIDE 0.115 mL in 100 mL

administration_route:

TOPICAL

prescription_type:

OTC DRUG

therapeutic_indication:

Antibacterial

authorization_status:

OTC monograph not final

SPC

                                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%
PURPOS E
Antibacterial
US ES
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
FRESH N UP
benzalkonium chloride solution
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:576 24-6 0 1
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
BENZALKO NIUM CHLO RIDE (UNII: F5UM2KM3W7) (BENZALKONIUM -
UNII:7N6 JUD5X6 Y)
BENZALKONIUM
CHLORIDE
0 .115 mL
in 10 0 mL
Rockline Industries, Inc
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
WATER (UNII: 0 59 QF0 KO0 R)
ALO E VERA LEAF (UNII: ZY8 1Z8 3H0 X)
METHYLCHLO RO ISO THIAZO LINO NE (UNII: DEL7T5QRPN)
METHYLISO THIAZO LINO NE (UNII: 229 D0 E1QFA)
EDETATE DISO DIUM (UNII: 7FLD9 1C8 6 K)
CITRIC ACID MO NO HYDRATE (UNII: 29 6 8 PHW8 Q
                                
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