Antibacterial Wipes by Tonic Bath & Body Products Shenzhen Ltd Drug Facts

Antibacterial Wipes by

Drug Labeling and Warnings

Antibacterial Wipes by is a Otc medication manufactured, distributed, or labeled by Tonic Bath & Body Products Shenzhen Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ANTIBACTERIAL WIPES- benzalkonium chloride swab 
Tonic Bath & Body Products Shenzhen Ltd

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.

----------

Drug Facts

Active Ingredient

Benzalkonium Chloride 0.1% v/v

Purpose

Antibacterial, Wipe

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

For external use only.

Flammable.

Keep away from fire and flame.

When using this product

When using this product avoid contact with eyes. In case of contact, rince eyes thoroughly with water.

Stop use and ask a doctor

Stop use and ask a doctor if irritation and redness develop.

Keep out of Reach of Children

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

Directions

  • Wet hands thoroughly with product and allow to dry.
  • Children under 6 years of age should be supervised with using this product.

Other information

  • Store between 20C to 25C (68F to 77F)
  • May discolor some fabrics or surfaces

Inactive Ingredients

Water(Aqua), Ethyl Alcohol, Glycerin, Propylene Glycol, Lavender Oil, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin, Fragrance (Parfum).

Package Label - Principal Display Panel

201250 100ct NDC: 43333-515-10

ANTIBACTERIAL WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43333-515
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43333-515-100.1 mL in 1 CANISTER; Type 0: Not a Combination Product09/02/202009/02/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A09/02/202009/02/2022
Labeler - Tonic Bath & Body Products Shenzhen Ltd (528197042)
Registrant - Tonic Bath & Body Products Shenzhen Ltd (528197042)
Establishment
NameAddressID/FEIBusiness Operations
Tonic Bath & Body Products Shenzhen Ltd528197042manufacture(43333-515)

Revised: 9/2021
 
Ton

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.