PERSONAL WASH CLOTHS- benzalkonium chloride cloth

Personal Wash Cloths by

Drug Labeling and Warnings

Personal Wash Cloths by is a Otc medication manufactured, distributed, or labeled by Ginni Filaments Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Benzalkonium Chloride 0.12%

Purpose

Antibacterial

(Helps reduce germs)

KEEP OUT OF REACH OF CHILDREN

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

INGREDIENTS AND APPEARANCE

PERSONAL WASH CLOTHS 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69089-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0155 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69089-101-10	10 in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/14/2014

Labeler - Ginni Filaments Limited (650793412)

Establishment
Name	Address	ID/FEI	Business Operations
Ginni Filaments Limited		650793412	manufacture(69089-101)