Drug Facts
Active Ingredient
Ethyl Alcohol 70% v/v
Biocare Labs Clean Hand Sanitizer
FDA Label NDC 54602-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Biocare Labs Inc. for the product Biocare Labs Clean Hand Sanitizer (NDC 54602-100). 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 drug facts, uses:, warnings:, otc - keep out of reach of children, do not use:, otc - when using, indications & usage, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
Hand Sanitizer to help decrease bacteria on the skin.
Warnings:
For external use only.
Flammable. Keep away from heat or flame.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN SECTION
If swallowed, get medical help or contact a Poison Control Center right away.
Do Not Use:
near or in the eyes. In case of contact, rinse eyes thoroughly with water.
Otc - When Using
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Indications & Usage
Stop use and ask a doctor if: if irritation or redness develop and lasts.
Directions:
• Wet hands thoroughly with product.
• Briskly rub hands together until dry.
• Supervise children under the age of 6 when using this product
Inactive Ingredients:
Deionized Water (Aqua, Eau), Glycerine, Melaleuca Alternafolia (Tea Tree) Leaf Oil,
Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Carbomer, Aminomethyl
Propanol, Acrylates Copolymer, Fragrance (Parfum), Polysorbate-20
Other Information:
• Store at 20°C to 25 °C (68° – 77° F)
• May discolor certain surfaces or fabrics.
For Questions:
Biocare Labs © 2020 Chicago, IL 60469
www.BiocareLabs.com
Package Label.Principal Display Panel
Clean Hand Sanitizer 2.0 Fl Oz (Cleanhand.sanitizer.2.0)
Clean Hand Sanitizer Packet (Clean.hand.sanitizer.packet)
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