HAND SANITIZER- benzalkonium chloride spray
Welch Materials (Zhejiang), Inc.

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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yuexu 0.13% BENZALKONIUM CHLORIDE

Directions

Take an appropriate amount of disinfectant to the palm, rub according to the hand disinfection code instructions, ensure that the sanitizer completely covers the skin of the hand sand wait for one minute until dry

Active Ingredient

Benzalkonium Chloride 0.3%

Purpose

Antibacterial

USE

Suitable for sanitary hand disinfection.

Warning

When using this product, avoid entering into the eyes.

Do not rub the eyes if accidental contact, rinse the eyes thoroughly with water for 15 minutes.

Those with silver allergies shall use with caution.

Keep out of reach of children.

If swallowed, seek medical help or contact a Poison Control Center immediately.

Inactive ingredients

Purified water, Glycerol, Silver Ion

50 ml NDC 81242-001-01 100ml NDC 81242-001-02 100

HAND SANITIZER
benzalkonium chloride spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:81242-001
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.3 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
SILVER CHLORIDE (UNII: MWB0804EO7)
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:81242-001-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020
2	NDC:81242-001-02	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	12/21/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	12/21/2020

Labeler - Welch Materials (Zhejiang), Inc. (543257165)

Registrant - Welch Materials (Zhejiang), Inc. (543257165)

Name	Address	ID/FEI	Business Operations
Establishment
Welch Materials (Zhejiang), Inc.		543257165	manufacture(81242-001) , label(81242-001)