Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antimicrobial
Biogeno Care Hand Sanitizer Gel (ethanol)
FDA Label NDC 77637-400
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dermacos Korea for the product Biogeno Care Hand Sanitizer Gel (ethanol) (NDC 77637-400). 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
Antimicrobial, Hand Sanitizer
Use
Hand sanitizer to help reduce bacteria on the skin.
Recommended for repeated use.
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
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 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
- Put enough product in your palm to cover hands and rub hands together briskly until dry.
- Children under 6 years of age should be supervised when using this product.
- Not recommended for infants.
Other Information
- Store at room temperature (33.8oF-86oF, 1oC-30oC) and avoid cold or dry place.
- May discolor certain fabrics or surfaces.
- Harmful to wood finishes and plastics.
Inactive Ingredients
Aloe Vera Gel, Carbomer, Fragrance (Lemon), Glycerin, Green Tea Extract, Purified Water, Rosa Damascena (Rose) Flower Water, Sodium Hyaluronate, Triethanolamine.
* Please review the disclaimer below.
