Active Ingredient(S)
Ethyl Alcohol 73.3%
Topicare Therapeutics Hand Sanitizer
FDA Label NDC 70112-300
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topicare Management, Llc for the product Topicare Therapeutics Hand Sanitizer (NDC 70112-300). 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.
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.
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.
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 occurs.
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
Wet hands thoroughly with product and allow to dry without wiping.
Other Information
Store between 15-30°C (59-86°F)
Avoid freezing and excessive heat above 40°C (104°F)
Inactive Ingredients
Klucel H hydroxypropyl cellulose, Deionized Water, Ceraphyl 31 ester, Glycerin
Package Label - Principal Display Panel
59mL NDC: 70112-300-02
118mL NDC 70112-300-04
236mL NDC 70112-300-08
473mL NDC 70112-300-16
3.79L NDC 70112-300-01
* Please review the disclaimer below.
