Exmicror BC by Biorganicos Robech, S. de R.L. de C.V. Hand Sanitizer 1000 mL

Exmicror BC by

Drug Labeling and Warnings

Exmicror BC 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]

EXMICROR BC- benzalkonium chloride solution 
Biorganicos Robech, S. de R.L. de C.V.

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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Hand Sanitizer 1000 mL

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.

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.

Warnings

For external use only.

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

glycerin USP, purified water USP

Package Label

1000 mL NDC: 77733-005-01

EXMICROR BC 
benzalkonium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 77733-005
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 77733-005-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/15/2020	12/31/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	10/15/2020	12/31/2020

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	label(77733-005) , manufacture(77733-005)

Revised: 12/2021

Document Id: d31f74e0-53ad-eee5-e053-2a95a90a433c

34390-5

Set id: b1e27918-24c6-2a0f-e053-2995a90a975f

Version: 3

Effective Time: 20211214