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.

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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

Inactive ingredients

Package Label - Principal Display Panel

80 pcs label 80 pcs label

ANTIBACTERIAL WIPES 
benzalkonium chloride cloth
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77490-013(NDC:52489-002)
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.0002 mL  in 1 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:77490-013-80360 mL in 1 PACKAGE; Type 0: Not a Combination Product05/27/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A05/27/2020
Labeler - On The Spot Products, LLC (117497833)
Registrant - On The Spot Products, LLC (117497833)
Establishment
NameAddressID/FEIBusiness Operations
On The Spot Products, LLC117497833relabel(77490-013)

Revised: 7/2020
Document Id: a97f175a-412a-0872-e053-2995a90a7f14
Set id: a97f0545-f776-eb5a-e053-2995a90a7887
Version: 1
Effective Time: 20200702
 
On The Spot Products, LLC