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.

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Drug Facts

Active Ingredient(s)

Benzalkonium Chloride 0.1% v/v. Purpose: Antiseptic

Purpose

Antibacterial, Wipe

Use

Hand sanitizer to help reduce bacteria on the skin.

Warnings

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

Do not use

  • in children less than 2 months of age
  • on open skin wounds

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

Directions

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

Other information

  • Store between 20-25C (68-77F)
  • Avoid freezing and excessive heat above 40C (104F)
  • May discolor some fabrics

Inactive ingredients

Water, Ethyl Alcohol, Glycerin, Propylene Glycol, Phenoxyethanol, Didecyldimethylammonium Chloride, Exylhexylglycerin.

Package Label - Principal Display Panel

201134-BDY 80ct NDC: 43333-505-80

ANTIBACTERIAL WIPES 
benzalkonium chloride swab
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43333-505
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
DIDECYLDIMONIUM CHLORIDE (UNII: JXN40O9Y9B)  
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43333-505-800.1 mL in 1 CANISTER; Type 0: Not a Combination Product07/15/202007/15/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A07/15/202007/15/2022
Labeler - Tonic Bath & Body Products Shenzhen Ltd (528197042)
Establishment
NameAddressID/FEIBusiness Operations
Tonic Bath & Body Products Shenzhen Ltd528197042manufacture(43333-505)

Revised: 9/2021
 
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