BENZALKONIUM CHLORIDE DISINFECTANT SANITIZER- hand sanitizer solution 
Beijing Supxing Biotech Co., 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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Active Ingredient(s)

Benzalkonium Chloride 0.5% w/w. Purpose: Antiseptic

Purpose

Antiseptic, Hand Sanitizer

Use

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Inactive ingredients

fragrance, glycerin, polyoxyl 40 hydrogenated castor oil, purified water USP.

Package Label - Principal Display Panel

60 mL NDC: 79278-594-01 Package Label

BENZALKONIUM CHLORIDE DISINFECTANT SANITIZER 
hand sanitizer solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79278-594
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
FRAGRANCE LAVENDER & CHIA F-153480 (UNII: SXS9CO2TZK) 0.01 g  in 100 mL
GLYCERIN (UNII: PDC6A3C0OX) 4 mL  in 100 mL
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F) 0.1 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 95.39 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:79278-594-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/29/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/29/202001/06/2021
Labeler - Beijing Supxing Biotech Co., Ltd. (414360579)
Registrant - Beijing Supxing Biotech Co., Ltd. (414360579)

Revised: 11/2021
 
Beijing Supxing Biotech Co., Ltd.