EXMICROR- benzalkonium chloride solution

Exmicror by

Drug Labeling and Warnings

Exmicror by is a Otc medication manufactured, distributed, or labeled by Biorganicos Robech, S. de R.L. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient(s)

Benzalkonium Chloride 0.13% w/v. Purpose: Antimicrobial

Purpose

Antimicrobial, 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.

Do not use

• in children less than 2 months of age
• on open skin wounds

WHEN USING

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

STOP USE

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

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

Inactive ingredients

Ascorbic acid, citric acid, glycerin USP, purified water USP.

EXMICROR 60ml - HAND SANITIZER

Exmicror 60ml - Hand Sanitizer NDC: 77733-002-04

EXMICROR 125ml - HAND SANITIZER

Exmicror 125ml - Hand Sanitizer NDC: 77733-002-05

EXMICROR 250ml - HAND SANITIZER

Exmicror 250ml - Hand Sanitizer NDC: 77733-002-06

EXMICROR 500ml - HAND SANITIZER

Exmicror 500ml - Hand Sanitizer NDC: 77733-002-07

EXMICROR 1000ml - HAND SANITIZER

Exmicror 1000ml - Hand Sanitizer NDC: 77733-002-03

EXMICROR 5000ml - HAND SANITIZER

Exmicror 5000ml - Hand Sanitizer NDC: 77733-002-08

INGREDIENTS AND APPEARANCE

EXMICROR 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77733-002
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
GLYCERIN (UNII: PDC6A3C0OX)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77733-002-03	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022
2	NDC: 77733-002-04	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022
3	NDC: 77733-002-05	125 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022
4	NDC: 77733-002-06	250 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022
5	NDC: 77733-002-07	500 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022
6	NDC: 77733-002-08	5000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	01/24/2022

Labeler - Biorganicos Robech, S. de R.L. de C.V. (951577331)

Registrant - Biorganicos Robech, S. de R.L. de C.V. (951577331)

Establishment
Name	Address	ID/FEI	Business Operations
Biorganicos Robech, S. de R.L. de C.V.		951577331	manufacture(77733-002) , label(77733-002)