Antibacterial Wipes by On The Spot Products, LLC Antibacterial Wipes

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by On The Spot Products, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WIPES- benzalkonium chloride cloth 
On The Spot Products, LLC

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.

----------

Antibacterial Wipes

Active Ingredient(s)

Benzalkonium Chloride%. Purpose: Antibacterial

Purpose

Antibacterial

Use

Antibacterial wet wipes to help reduce bacteria on the skin.

Warnings

For external use only. Flammable. Keep away from heat or flame

When using this product do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash appears and lasts.

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

Directions

• Wipe skin with the product and allow tol dry.
• Discard wipes in trash receptacle after use. Do not flush.
• Children under 6 years of age should be supervised when using this product.

Inactive ingredients

Package Label - Principal Display Panel

80 pcs label

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77490-013(NDC: 52489-002)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)	0.0002 mL  in 1 mL
CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)	0.0002 mL  in 1 mL
CHLORPHENESIN (UNII: I670DAL4SZ)	0.0002 mL  in 1 mL
PROPYLENE GLYCOL, (S)- (UNII: 942194N4TD)	0.0002 mL  in 1 mL
GLYCEROL FORMAL (UNII: 3L7GR2604E)	0.0002 mL  in 1 mL
WATER (UNII: 059QF0KO0R)	0.9941 mL  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77490-013-80	360 mL in 1 PACKAGE; Type 0: Not a Combination Product	05/27/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	05/27/2020	12/15/2022

Labeler - On The Spot Products, LLC (117497833)

Registrant - On The Spot Products, LLC (117497833)

Establishment
Name	Address	ID/FEI	Business Operations
On The Spot Products, LLC		117497833	relabel(77490-013)

Revised: 7/2022

Document Id: e3dde1a0-d6e0-732c-e053-2a95a90a10a1

34390-5

Set id: a97f0545-f776-eb5a-e053-2995a90a7887

Version: 4

Effective Time: 20220715