BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER- benzalkonium chloride instant hand sanitizer liquid
Dongguan Mingyi Medical Products 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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74046-006
Benzalkonium Chloride Instant Hand Sanitizer

Active Ingredients

Benzalkotlm Chloide 0.13% v/v

Purpose

Antiseptic

Uses

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 eyas, 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.

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 15-30℃ ( 59-86℉)

Avcid freezing and excessive heat above 40℃ ( 104℉)

Inactive Ingredients

aloe , glycerin , sterile distilled watet

Package Label - Principal Display Panel

74046-006-01 74046-006-02 74046-006-03 74046-006-04 74046-006-05 74046-006-06 74046-006-07 74046-006-08 74046-006-09 74046-006-10

BENZALKONIUM CHLORIDE INSTANT HAND SANITIZER
benzalkonium chloride instant hand sanitizer liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:74046-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.13 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE (UNII: V5VD430YW9)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:74046-006-01	10 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
2	NDC:74046-006-02	15 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
3	NDC:74046-006-03	20 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
4	NDC:74046-006-04	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
5	NDC:74046-006-05	40 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
6	NDC:74046-006-06	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
7	NDC:74046-006-07	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
8	NDC:74046-006-08	100 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
9	NDC:74046-006-09	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022
10	NDC:74046-006-10	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/15/2022

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	01/15/2022

Labeler - Dongguan Mingyi Medical Products Co., Ltd. (554526907)

Registrant - Dongguan Mingyi Medical Products Co., Ltd. (554526907)

Name	Address	ID/FEI	Business Operations
Establishment
Dongguan Mingyi Medical Products Co., Ltd.		554526907	manufacture(74046-006)

74046-006 Benzalkonium Chloride Instant Hand Sanitizer