Active Ingredient(S)
Hypochlorous acid 111 mg/L. Purpose: Kill pyogenic coccus, intestinal pathogenic bacteria, pathogenic yeast, and common bacteria of hospital infection.
Cela No-clean Hypochlorous Acid Disinfectant
FDA Label NDC 75318-0106
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Shanghai Wanlay Environmental Protection Technology Co., Ltd. for the product Cela No-clean Hypochlorous Acid Disinfectant (NDC 75318-0106). 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, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.
Use
It is suitable for surgical hand antisepsis, hygienic hand antisepsis, skin disinfection (including damaged skin), disinfection of mucous membrane, general subject surface disinfection and air disinfection.
Warnings
External Use Only.
Keep out of reach children.
❶ Can’t mix with other product;
❷ Keep out of the sunlight, store in cool dry place, sealed preservation;
❸ Undrinkable water.
Do Not Use
- on children less than 2 months of age
- on open skin wounds
- mixing this product with other disinfectants
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.
This product is for external use. It should not be taken orally.
This product has a certain corrosive effect on metal objects other than stainless steel, and should be used with caution.
When sterilizing articles containing more organic objects, they should be completely removed and then disinfected.
Use with caution for those with sensitive skin.
Do not mix this product with other disinfectants.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Other Information
Storage: place it in a normal temperature and light-shielded environment.
Directions
| Content | exposure time | Methods |
| hygienic hand antisepsis | 1min | After washing hands, spray the product directly on both hands and rub |
| surgical hand antisepsis | 3min | Wash and dry hands, forearms and lower upper arms with soap solution, then spray with appropriate amount of disinfectant and rub until dry |
| disinfection of skin and mucous membranes | 3min | Spray, repeatedly wipe or soak |
| general subject surface disinfection | 3min | spray, wipe or soak with the product directly |
| air disinfection | 30min | spray with the product directly in the air with the dosage of 10ml/m3 |
Inactive Ingredients
Sodium chloride, Water
Package Label - Principal Display Panel
5l-c (5l C)
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