Active Ingredient(S)
EthylAlcohol 80%. Purpose: Antibacterial
Antibacterial Alcohol Wipes
FDA Label NDC 80924-110
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Urigel for the product Antibacterial Alcohol Wipes (NDC 80924-110). 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
Antibacterial, Hand Sanitizer
Use
For handwashing to decrease bacteria on skin.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- on children less than 2 months of age
- on open skin wounds
- over large areas of the body or if you are allergic to any of these ingredients.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, 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, get medical help or contact a Poison Control Center right away.
Directions
- To use, pull out wipe and reseal container to maintain moisture.
- Unfold cloth and rub thoroughly over all surfaces of both hands. Use only once and dispose of wipein a trash receptacle.
- Do not flush.
- Rub hands together briskly to dry.
Other Information
- Store between 59-86 °F (15-30 °C)
- Avoid freezing and excessive heat
- Dispose of contents/container responsibly
Inactive Ingredients
Water, Glycerin.
Principal Display Panel 450 Units
80 Each Sanitizer Wipes
80 Each NDC: 80924-110-01
100 Each Sanitizer Wipes
100 Each NDC:80924-110-02
450 Sanitizer Wipes
450 Each NDC:80924-110-03
* Please review the disclaimer below.
