Your browser does not support JavaScript! ANTIBACTERIAL WET WIPES (BENZALKONIUM CHLORIDE) SWAB [MC GROUP DEVELOPMENT LTD. ]
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ANTIBACTERIAL WET WIPES (benzalkonium chloride) swab
[MC Group Development Ltd. ]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Active Ingredient

Benzalkonium Chloride

Purpose

Antibacterial

Use

For hand washing to decrease bacteria on the skin.May be used on face,arms and legs.

WARNINGS

For External use only.
Keep out of eyes,Incase of contact,rinse with water.If irritation or rash develops,discontinue use .Consult doctor if irritation persists for more than 72 hours,If swallowed,seek medical attention or contact a Poison Control Center.

keep out of reach of children

keep out of reach of children

Directions

Open resealable label.Pull one sheet from pack.Clean hands or affected area and discard.Re-seal label after each use to keep wipes fresh.

Inactive ingredients

Iodopropynyl Butylcarbamate,DMDM Hydantoin,Lauryl Glucoside,Glycerin,D-Panthenol,Tocopheryl Acetate,Chamomilla Recutita Extract,PEG-12 Dimethicone,Disodium EDTA,Aloe Barbadensis Leaf Extract,Allantoin,Water

image description

ANTIBACTERIAL WET WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50672-838
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Benzalkonium Chloride (BENZALKONIUM) Benzalkonium Chloride0.1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
Iodopropynyl Butylcarbamate 
DMDM Hydantoin 
Lauryl Glucoside 
GLYCERIN 
DEXPANTHENOL 
TOCOPHERYL NICOTINATE, D-.ALPHA. 
MATRICARIA RECUTITA 
PEG-12 DIMETHICONE (300 CST) 
DISODIUM EDTA-COPPER 
ALOE VERA LEAF 
Allantoin 
Packaging
#Item CodePackage Description
1NDC:50672-838-013.3 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A11/12/2012
Labeler - MC Group Development Ltd. (527868588)
Establishment
NameAddressID/FEIBusiness Operations
MC Group Development Ltd.527868588manufacture(50672-838)

Revised: 11/2012
Document Id: 93d9496a-952d-456b-9738-fceb351103b6
Set id: 20aabff1-9aca-4cfd-9161-9f591ecf44a8
Version: 1
Effective Time: 20121112
 
MC Group Development Ltd.

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