Active Ingredient(s)

Alcohol 70% 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

purified water USP, alcohol, sodium nitrite.

Package Label - Principal Display Panel

65 mL NDC:78084-003-01

120 mL NDC: 78084-003-02 120

240 mL NDC: 78084-003-03 240

330 mL NDC: 78084-003-04 330

DARANJO
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78084-003
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	1.3 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM NITRITE (UNII: M0KG633D4F)	0.3 g in 1000 mL
ALCOHOL (UNII: 3K9958V90M)	4 mL in 1000 mL
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:78084-003-01	65 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020
2	NDC:78084-003-02	120 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020
3	NDC:78084-003-03	240 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020
4	NDC:78084-003-04	330 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/07/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	09/07/2020

Labeler - Matilde Gómez López (951577135)

Registrant - Matilde Gómez López (951577135)

Name	Address	ID/FEI	Business Operations
Establishment
Matilde Gómez López		951577135	manufacture(78084-003) , pack(78084-003) , label(78084-003)