PERSONAL WASH CLOTHS- benzalkonium chloride  cloth 
Ginni Filaments Limited

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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Personal Wash Cloths

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antibacterial

(Helps reduce germs)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Uses

Helps kill germs that can potentially cause infection. 
Helps eliminate odor. 

Reduces cross contamination

Warnings

For external use only

Avoid direct contact with eyes.
Do not use on deep or punctured wounds, serious burns, animal bites

If irritation or redness develops, and persists for more than 72 hours, stop use and seek medical help.

Directions

Washcloths can be used at room temperature or heated in a microwave for extra comfort. 

Use one wash cloth for each of the following areas

1. Face, Neck, Chest 2. Left and right arm, 3. Perineum, 4.Left and Right leg, 5.Back and Buttocks

Heating instructions

Place full packet in microwave, peel open label approx. 1 inch and heat for 15 seconds, then, follow bathing instructions.(test temperature to avoid burning skin) gloved hands may reduce sensitivity to heat. Check temperature for infants or skin sensitive individuals

Do not overheat! Do not reheat.

Other informations

Protect from freezing

Wash cloth: Spun lace fabric

INACTIVE INGREDIENTS

Deionized water,Propylene Glycol, Glycerin,DMDM Hydantoin, Disodium cocoampho Diacetate, Cocoamide Propyl Betaine, Phenoxyethanol, Dimethicon copolyol(DC-193), DC-245, Polysorbate 20, Peg -40 -Hydrogenated Castor Oil, EDTA Disodium, Vitamin E, Citric Acid/TEA, Fragrance

packaging

LEADING AGE

PERSONAL WASH CLOTHS 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69089-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.0155 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
DMDM HYDANTOIN (UNII: BYR0546TOW)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69089-101-1010 in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/14/2014
Labeler - Ginni Filaments Limited (650793412)
Establishment
NameAddressID/FEIBusiness Operations
Ginni Filaments Limited650793412manufacture(69089-101)

Revised: 11/2014
Document Id: 1ae3422d-9b8e-4297-8ecd-bd0655a5e62f
Set id: af336d16-e9e3-4532-9369-157cd4512ee5
Version: 1
Effective Time: 20141123
 
Ginni Filaments Limited