0.13% Benzalkonium Chloride Instant Hand Sanitizer by Hangzhou Wellbeing Technology Co., Ltd.

0.13% Benzalkonium Chloride Instant Hand Sanitizer by

Drug Labeling and Warnings

0.13% Benzalkonium Chloride Instant Hand Sanitizer by is a Otc medication manufactured, distributed, or labeled by Hangzhou Wellbeing Technology Co., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- hand sanitizer gel 
Hangzhou Wellbeing Technology 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 0.13% v/v. 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

aloe, glycerin, sterile distilled water.

Package Label - Principal Display Panel

100 mL NDC: 78416-019-02 Package Label

Package Label - Principal Display Panel

60 mL NDC: 78416-019-03 Package Label

Package Label - Principal Display Panel

58 mL NDC: 78416-019-01 Package Label

Package Label - Principal Display Panel

3800 mL NDC: 78416-019-06 Package Label

Package Label - Principal Display Panel

Package Label - Principal Display Panel

240 mL NDC: 78416-019-04 Package Label

Package Label - Principal Display Panel

500 mL NDC: 78416-019-07 Package Label

0.13% BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER 
hand sanitizer gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 78416-019
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.14 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
GLYCERIN (UNII: PDC6A3C0OX) 2.88 mL  in 100 mL
WATER (UNII: 059QF0KO0R) 96.89 mL  in 100 mL
ALOE (UNII: V5VD430YW9) 0.09 mL  in 100 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 78416-019-0158 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
2NDC: 78416-019-02100 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
3NDC: 78416-019-0360 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
4NDC: 78416-019-063800 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/04/2020
5NDC: 78416-019-04240 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2020
6NDC: 78416-019-07500 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product06/23/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A06/04/202012/31/2021
Labeler - Hangzhou Wellbeing Technology Co., Ltd. (414010999)
Registrant - Hangzhou Wellbeing Technology Co., Ltd. (414010999)
Establishment
NameAddressID/FEIBusiness Operations
Hangzhou Wellbeing Technology Co., Ltd.414010999manufacture(78416-019)

Revised: 4/2022
 

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