KLEENSWEEP ANTIBACTERIAL WIPES- antibacterial wipes swab

KleenSweep Antibacterial Wipes by

Drug Labeling and Warnings

KleenSweep Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Savannah Solutions, Inc., Zhejiang Ruolin Hygienic Products Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Antibacterial wipes kill 99.9% of germs and help prevent the spread of bacterial. They remove dirt, providing a better clean than sanitizers. They are ideal for quick clean-ups after contact with germs, sticky food, greasy dirt, and everyday messes. Antibacterial wipes are formulated to be tough on dirt and germs, yet gentle on skin. Help keep your family healthy and clean anytime and anywhere when soap and water are not available.

The ingredients are as follows:

Benzalkonium Chloride :0.1%

Glycerin :0.1%

Ethylhexylglycerin :0.1%

Phenoxyethanol:0.5%

Didecyldimethylammonium Chloride :0.2%

Alcohol:10%

Propylene Glycol :0.1%

Water :88.9%.

Active Ingredient(s)

Benzalkonium Chloride 0.135%

Purpose

Antiseptic, Wipes

Use

Pre-moistened towelettes that contain a sanitizing or disinfecting formula that kill or reduce germs on surfaces and skin

Warnings

Liquid may cause irritation to the eyes. Prolonged or repeated contact may dry skin and cause
irritation and sensitization. Harmful if swallowed.

Do not use

• Skin Contact: Skin irritation is not expected. Should irritation develop, discontinue use. Wash affected skin

thoroughly with soap and water. Get medical attention if irritation or other symptoms develop or persist.

• Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids

occasionally. Get medical attention if irritation persists.

• Inhalation: Normal use of this product does not pose an inhalation hazard. Should respiratory tract irritation

develop, discontinue use and remove to fresh air. Get medical attention if irritation or other symptoms persist or
develop.

• Ingestion: Seek medical attention immediately. Never give anything by mouth to an unconscious person. DO

NOT induce vomiting. If vomiting occurs, keep head below hips to prevent aspiration of liquid into lungs.

WHEN USING

• Skin Contact: Skin irritation is not expected. Should irritation develop, discontinue use. Wash affected skin

thoroughly with soap and water. Get medical attention if irritation or other symptoms develop or persist.

• Eye Contact: Immediately flush eyes with plenty of water for at least 15 minutes, lifting lower and upper eyelids

occasionally. Get medical attention if irritation persists.
Inhalation: Normal use of this product does not pose an inhalation hazard. Should respiratory tract irritation
develop, discontinue use and remove to fresh air. Get medical attention if irritation or other symptoms persist or
develop.

• Ingestion: Seek medical attention immediately. Never give anything by mouth to an unconscious person. DO

NOT induce vomiting. If vomiting occurs, keep head below hips to prevent aspiration of liquid into lungs.

STOP USE

Emergency Overview:
WARNING! Liquid may cause irritation to the eyes. Prolonged or repeated contact may dry skin and cause
irritation and sensitization. Harmful if swallowed.

Potential Health Effects
Route of entry: Inhalation, skin contact, eye contact, ingestion.
Skin Contact: Frequent or prolonged contact with skin may cause irritation.
Eye Contact: May cause eye irritation. Symptoms may include stinging, tearing and redness.
Inhalation: Not expected to be a significant exposure route. Vapor or mist may be irritating to mucous
membranes and upper respiratory tract.
Ingestion: May cause gastrointestinal irritation with nausea, vomiting and diarrhea.

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.

Directions

• Rub surfaces with wipes and wash your hands afterward

Other information

• Handling: Avoid contact with eyes. Do not eat or drink when handing. Keep ventilation. Use in accordance with

product literature.

• Storage: Store product at room temperature. Keep in a closed package. Protect against physical damage.

Observe all warnings and precautions listed for the product.

Inactive ingredients

Water,Glycerin,Ethylhexylglycerin,Phenoxyethanol,Didecyldimonium Chloride, Alcohol, Propylene Glycol

Package Label - Principal Display Panel

INGREDIENTS AND APPEARANCE

KLEENSWEEP ANTIBACTERIAL WIPES 
antibacterial wipes swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 88888-001
Route of Administration	TOPICAL

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
ALCOHOL (UNII: 3K9958V90M)
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLENE GLYCOL 2-BEHENATE (UNII: 1L33JV6CWK)
GLYCERIN (UNII: PDC6A3C0OX)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 88888-001-50	202.5 g in 1 BAG; Type 0: Not a Combination Product	07/01/2020
2	NDC: 88888-001-70	264.6 g in 1 TUBE; Type 0: Not a Combination Product	07/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	07/01/2020

Labeler - Savannah Solutions, Inc. (024263561)

Establishment
Name	Address	ID/FEI	Business Operations
Zhejiang Ruolin Hygienic Products Co., Ltd.		415426870	manufacture(88888-001)