ANTIBACTERIAL WET WIPES- benzalkonium chloride swab 
MC Group Development Ltd.

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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Antibacterial Wet Wipes

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 Type HUMAN OTC DRUG Item Code (Source) NDC:50672-838
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride 0.1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)  
DMDM Hydantoin (UNII: BYR0546TOW)  
Lauryl Glucoside (UNII: 76LN7P7UCU)  
GLYCERIN (UNII: PDC6A3C0OX)  
DEXPANTHENOL (UNII: 1O6C93RI7Z)  
TOCOPHERYL NICOTINATE, D-.ALPHA. (UNII: WI1J5UCY5C)  
MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ)  
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Allantoin (UNII: 344S277G0Z)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50672-838-01 3.3 g in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 11/12/2012
Labeler - MC Group Development Ltd. (527868588)
Establishment
Name Address ID/FEI Business Operations
MC Group Development Ltd. 527868588 manufacture(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.