Active Ingredient(S)
Hypochlorous acid 0.015%
Mundus Hypochlorous Acid Hand Sanitizer
FDA Label NDC 55683-003
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Jiacheng Tech (zhejiang) Co., Ltd. for the product Mundus Hypochlorous Acid Hand Sanitizer (NDC 55683-003). 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 active ingredient(s), purpose, use, warnings, do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Antiseptic, Hand Sanitizer
Use
Used to wash hands to help reduce bacteria that potentially can cause disease.
Warnings
- For external use only.
- Keep away from heat.
Do Not Use
- in children less than 2 months of age.
- on open skin wounds.
Otc - When Using
When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. if swallowed, ger 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 13-30℃.
- Avoid freezing and excessive heat above 40℃.
Inactive Ingredients
Hypochlorite Ion, Sodium Chloride(Salt), lonized Water.
Package Label - Principal Display Panel
480 mL NDC: 55683-002-01
480ml Label (480ml)
100 mL NDC: 55683-002-02
100ml Label (100ml)
25000 mL NDC: 55683-002-03
25000ml Label (25l)
10000 mL NDC: 55683-002-04
10000ml Label (10l)
60 mL NDC: 55683-002-05
60ml Label (60ml)
80 mL NDC: 55683-002-06
80ml Label (80ml)
300 mL NDC: 55683-002-07
300ml Label (300ml)
500 mL NDC: 55683-002-08
500ml Label (500ml)
* Please review the disclaimer below.
