Other
This is hand sanitizer manufactured according to OTC Monograph part 333a
Mi
FDA Label NDC 81563-013
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Infinity Manufacturing Of America, Llc for the product Mi (NDC 81563-013). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, purpose, warnings, do not use-otc, when using section, stop use section, keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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,
Otc - 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
Package Label.Principal Display Panel
473ml NDC:81563-013-16
16 Oz (16oz)
946ml NDC:81563-013-32
32 Oz (32oz 1)
3785 ml NDC: 81563-013-00
128 Oz (128oz 2)
236ml NDC: 81563-013-08
8 (8oz)
* Please review the disclaimer below.
