Mellow Instant Hand Sanitizer 8 Oz
FDA Label NDC 70108-033
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Ashtel Studios, Inc for the product Mellow Instant Hand Sanitizer 8 Oz (NDC 70108-033). 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, medicinal ingredient, purpose, non medicinal, features, directions, warning, 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
Medicinal Ingredient
Ethyl Alcohol 62%
Purpose
Antiseptic
Non Medicinal
Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Parfum, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, FD&C Yellow No. 5(Tartrazine), FD&C Blue No. 1
Features
♦ To decrease bacteria on the skin that could cause disease.
♦ Recommended for repeated use.
♦ Use anywhere without water.
Directions
♦ Wet hands thoroughly with product and rub until dry without wiping.
♦ For children under 6, use only under adult supervision.
♦ Not recommended for infants.
Warning
♦ For external use only-hands.
♦ Flammable. Keep away from heat and flame.
♦ Discontinue if skin becomes irritated and ask a doctor.
When using this product
♦ Keep out of eyes. In case of contact with eyes, flush thoroughly with water.
♦ Do not inhale or ingest.
♦ Avoid contact with broken skin.
Otc - Keep Out Of Reach Of Children
♦ Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Other Information
♦ Do not store above 105°F
♦ May discolor some fabrics,
♦ Harmful to wood finishes and plastics.
Packaging
Image Description (Label1.1)
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