Active Ingredient[S]
Ethanol 72%
Dr.clean
FDA Label NDC 76850-201
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ph Holdings for the product Dr.clean (NDC 76850-201). 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[s], warnings, do not use, when using this product, stop use and ask a doctor, 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
Use[S]
Hand Sanitizer to help reduce bacteria that potentially can cause disease.
For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame.
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.
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.
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 Ingredient[S]
Purified Water, Acrylate/C10-30 Alkyl Acrylate Cross Polymer, Glycerin, Tromethamine
Precautions For Use
1. If you have any of the following abnormalities using the product,
you must stop using it and as it worsens, please consult a dermatologist, etc.
(While you are using, there are abnormalities such as red spots, swelling,
itching, irritation, etc. and the applied area has the above-mentioned
abnormalities due to direct sunlight)
2. Do not use on areas with wounds or areas with eczema and dermatitis.
3. If it gets into your eyes, wash them immediately with water.
4. Precautions for storage and handling
▷ After use, be sure to close the cap.
▷ Keep out of reach of children.
▷ Do not store in a place with high or low temperature and direct sunlight.
5. This product is not a food / beverage, so do not use it for any purpose
other than its original purpose. If you ingest it, be sure to consult a doctor.
6. Be careful not to get on clothes.
7. Please note that there is a risk of slipping when in contact with the product contents.
* Please review the disclaimer below.
