Hawaiian Passion Hand Sanitizer
FDA Label NDC 50157-106

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Brands International for the product Hawaiian Passion Hand Sanitizer (NDC 50157-106). 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, purpose, uses, warnings, otc - keep out of reach of children, otc - when using, otc - stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredients

Ethyl Alcohol 62%

Purpose

Antiseptic

Uses

  • To decrease bacteria on the skin and clean hands.
  • Recommended for repeated use.

Warnings

For external use only.

Flammable. Keep away from fire or flame.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center right away.

Otc - When Using

Do not get into eyes. If contact occurs, rinse thoroughly with water.

Otc - Stop Use

Discontinue use if irritation or redness develop. If irritation persists for more than 72 hours, consult a doctor.

Directions

  • apply to hands until thoroughly wet
  • rub vigorously until dry
  • supervise children in the use of this product.

Other Information

  • may discolor certain fabrics or surfaces.
  • do not store above 110°F (43°C)

Inactive Ingredients

Water, Isopropyl Alcohol, Glycerin, Carbomer, Aminomethyl Propanol, Fragrance, Propylene Glycol, Isopropyl Myristate, Aloe Barbadensis Leaf Juice, Tocopheryl (Vitamin E) Acetate, Sunflower (Helianthus Annus) Seed Extract, Grapefruit (Citrus Grandis) Seed Extract, Red 33 (CI 17200).

Package Label

HAWAIIAN PASSION

ANTIBACTERIAL

Hand Sanitizer Gel


Kills 99.99% of Germs
1 FL OZ (29 ml)

Label (Image 01)

Label (Image 01)

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