MI- benzalkonium chloride hs solution

Mi by

Drug Labeling and Warnings

Mi by is a Otc medication manufactured, distributed, or labeled by Infinity Manufacturing of America, LLC, Bama-Bio Tech Corporation, Infinity Manufacturing of America. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL Unclassified Section

This is hand sanitizer manufactured according to OTC Monograph part 333a

Purpose

Antiseptic, Hand Sanitizer

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON CHILDREN UNDER 2 MONTHS OF AGE

WHEN USING THIS PRODUT

KEEP OUT OF EYES, EARS AND MOUTH

IN CASE OF CONTACT WITH EYES, RINSE EYES THPROUGHLY WITH WATER

STOP USE AND CONTACT A PHYSICIAN IF IRRITATION OR

RASH OCCUR

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, CALL POISON CONTROL IMMEDIATELY

Do Not Use-OTC

on children less than 2 mos in age on open skin wounds.

When Using Section

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 Section

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condidtion.

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.

DOSAGE & ADMINISTRATION

PLACE PRODUCT IN HANDS TO COVER ALL SURFACES, RUB

TOGETHER UNTIL DRY

CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED

WHILE USING PRODUCT

INACTIVE INGREDIENTS IONIZED WATER, CARBAMIDE

Storage and Handling

Store between 15-30C (59-86F)

Avoid freezing and excessive heat above 40C(104F)

Inactive Ingredients

Ionized Water, Carbamide

INDICATIONS & USAGE

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,

ACTIVE INGREDIENT

BENZALKONIUM CHLORIDE 0.13% v/v..................ANTIBACTERIAL

Active Ingredients

BENZALKONIUM CHLORIDE 0.13% v/v..................ANTIBACTERIAL

Uses

HAND SANITIZER TO DECREASE BACTERIA ON THE SKIN

RECOMMENDED FOR REPEATED USE

PRINCIPAL DISPLAY PANEL

473ml NDC: 81563-013-16

PRINCIPAL DISPLAY PANEL

946ml NDC: 81563-013-32

PRINCIPAL DISPLAY PANEL

3785 ml NDC: 81563-013-00

PRINCIPAL DISPLAY PANEL

236ml NDC: 81563-013-08

INGREDIENTS AND APPEARANCE

MI 
benzalkonium chloride hs solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 81563-013(NDC:78003-120)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y)	BENZALKONIUM CHLORIDE	0.0013 g  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
UREA (UNII: 8W8T17847W)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 81563-013-08	236 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/23/2021
2	NDC: 81563-013-16	473 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/23/2021
3	NDC: 81563-013-32	946 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/23/2021
4	NDC: 81563-013-00	3785 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	02/23/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	02/23/2021

Labeler - Infinity Manufacturing of America, LLC (117711498)

Registrant - Bama-Bio Tech Corporation (117525750)

Establishment
Name	Address	ID/FEI	Business Operations
Infinity Manufacturing of America		117711498	relabel(81563-013)