PRE-MOISTENED BATHING CLOTHS- benzalkonium chloride cloth

PRE-MOISTENED BATHING CLOTHS by

Drug Labeling and Warnings

PRE-MOISTENED BATHING CLOTHS by is a Otc medication manufactured, distributed, or labeled by Leading Age Supplies, Ginni Filaments Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.10%

Purpose

Antibacterial

(helps reduce germs)

Uses

Helps kill germs that can potentially cause infection. 

Helps eliminate odor. 

Reduces cross contamination.

Warnings

For external use only.

Avoid contact with eyes.

Do not use on deep or punctured wounds, serious burns or animal bites. If irritation or redness develops, and persists for more than 72 hours after use, stop use and seek medical help.

Keep out of reach of children.

If swallowed, get medical help or contact poison control center immediately.
AAPCC: (800) 222-1222

DIRECTIONS FOR USE

Remove one cloth at a time, cleanse the body as diagrammed below. No rinsing or drying is necessary. Use one pre-moistened
cloth for each of the following areas:

DO NOT FLUSH! Dispose bathing cloths in trash

Other Information

Protect from freezing. Pre-moistened bathing cloths made from spunlace fabric.

Inactive Ingredients

Water, Propylene Glycol, Glycerine, Phenoxyethanol, Benzoic Acid, Dehydroacetic Acid, Cocamidopropylbetaine, Peg-12 Dimethicone, Disodium
Cocoamphodiacetate, Polysorbate-20, Cyclopentasiloxane 5, Sodium Gluconate, Peg-40 Hydrogenated Castor Oil, Fragrance, Alpha Tocopheryl Acetate (Alpha Tocopheryl/Vitamin E), Citric Acid.

SPL UNCLASSIFIED SECTION

A soft, convenient, and easy to use bathing alternative

ALCOHOL FREE pH BALANCED
ANTI BACTERIAL MICROWAVEABLE
LATEX FREE HYPOALLERGENIC
VITAMIN E ENRICHED

CHG COMPATIBLE

Healthcare Facilities - Home Care Hikers - Cyclists - Campers - Truckers

MICROWAVEABLE
Pull Back the resealable tab approximately 1 inch and heat for 30 seconds.
DO NOT OVERHEAT. DO NOT REHEAT.

TEST TEMPERATURE TO AVOID BURNING SKIN.
Check temperature prior to use, especially for infants or skin sensitive individuals.
Remove gloves; heat sensitivity is reduced when wearing gloves.

PRECAUTIONS
Avoid direct contact with eyes. To prevent drying, do not store under sunlight or in high temperatures.
Re-seal front label after each use.

SPECIALLY MANUFACTURED
FOR LEADING AGE SUPPLIES
24700 Chagrin Blvd., Suite 104
Cleveland, Ohio 44122
www.bathinbag.com

Packaging

INGREDIENTS AND APPEARANCE

PRE-MOISTENED BATHING CLOTHS 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69088-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.143 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BENZOIC ACID (UNII: 8SKN0B0MIM)
DEHYDROACETIC ACID (UNII: 2KAG279R6R)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
SODIUM GLUCONATE (UNII: R6Q3791S76)
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69088-102-08	8 in 1 BAG; Type 0: Not a Combination Product	11/01/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	11/01/2019

Labeler - Leading Age Supplies (079338636)

Establishment
Name	Address	ID/FEI	Business Operations
Ginni Filaments Limited		650793412	manufacture(69088-102)