The following Structured Product Label (SPL) was submitted to the FDA by Landy International for the product Hand Sanitizer (NDC 51706-500). 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, purpose, uses, warning, keep out of reach of children., directions, other information, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Active Ingredient
Ethyl Alcohol 63%
Purpose
Uses
To decrease bacteria on the skin.
Warning
For external use only.Flammable.Keep away from heat and flame.When using this product■ Avoid contact with eyes. If contact occurs, flush eyes with water. ■ Avoid contact with broken skin.Stop use and consult a doctorif irritation and redness develop and persist for more than 72 hours.
Keep Out Of Reach Of Children.
In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
Directions
■ Wet hands with product and allow to dry without wiping. ■ Not recommended for infants.
■ Store at 68 o to 77 oF (20 o to 25 oc). ■ Do not store above 105 oF. ■ May discolor some fabrics. ■ Harmful to wood finishes and plastics.
Inactive Ingredient
Alcohol Denat., Water, Propylene Glycol, Fragrance, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Triethanolamine, Lactose, Cellulose, Hydroxypropyl Methylcellulose, Jojoba Esters, Tocopheryl Acetate, Blue 1(CI 42090), Red 33(CI 17200), Red 4(CI 14700). Yellow 5(CI 19140),
Package Label.Principal Display Panel
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Phot Of Druglisting (Label)
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