Active Ingredient(S)
Benzalkonium chloride>=0.1%, Antimicrobial agent
Sanitizing Wipes
FDA Label NDC 79247-812
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ivy Rose Inc. for the product Sanitizing Wipes (NDC 79247-812). 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
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.
Do Not Use
if you are allergic to any of the ingredients.
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.
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 - Stop Use
Stop use and ask a doctor if irritation or rash develops and continues for more than 72 hours.
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
- Adults and children 2 years and over.
- Apply to hands allow to dry without wiping.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
Water(aqua), Didecyl dimethy ammonium chloride, T5(Glycerin), T3(Aloe), T6(VE), Tributyl phosphate, Citric acid, Alcohol.
Package Label - Principal Display Panel
30 Individually Packed Wipes in 1 BOX NDC: 79247-812-01
20 Wipes in 1 BOX NDC: 79247-812-02
50 Wipes in 1 BOX NDC: 79247-812-03
80 Wipes in 1 BOX NDC: 79247-812-04
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