Active Ingredients
Alcohol 70% v/v
Hand Sanitizer Gel
FDA Label NDC 78994-070
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Rfh Biotek Inc. for the product Hand Sanitizer Gel (NDC 78994-070). 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 ingredients, purpose, use, warnings, do not use, when using this products, 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
This rinse-free hand gel moisturizes the hands while cleaning and helps to 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. Avoid contact with broken skin.
When Using This Products
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 appears and lasts.
Keep Out Of Reach Of Children
If swallowed, get medical help and contact a Poison Control Centre right away.
Directions
Put enough product in palm to cover hands. Rub briskly until dry. Supervise children under 6 years of age.
Other Information
Store in a cool, dry place, keep away from direct sunlight. Store between 15-30C (59-86F). Avoid Freezing and excess heat above 40C (104F).
Inactive Ingredients
WATER, GLYCERIN, CAPRYLYL GLYCOL, ETHYLHEXYLGLYCERIN, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, AMINOMETHYL PROPANOL, SILVER.
Package Label.Principal Display Panel
HAND SANITIZER
GEL WITH pure SILVER
- Cleans & care for hands
- Provides moisture & refreshes
- Dries fast and is not sticky
- Improves hand hygiene by reducing bacteriria
MicroSilver
BG™
99.99%
ANTIBACTERIAL
* Please review the disclaimer below.
