Instant Hand Sanitizer
FDA Label NDC 69410-0001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Primecare + Inc. for the product Instant Hand Sanitizer (NDC 69410-0001). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient
75% Ethyl Alcohol

Otc - Purpose

PurposeAntiseptic

Indications & Usage

Uses:

  • For hand washing to decrease bacteria/microorganisms on the skin that can cause diseases.
  • Recommended for repeated use.

Warnings

Warnings:   
◊ For external use only. Avoid contact with broken skin.                                                                                                                                   
◊ Flammable, keep away from heat, flame or fire.                                                                                                                                                                                                                                               ◊ Do not use this product,in or near the eyes.
◊ If eye contact, immediately rinse thoroughly with a lot of water.

Otc - Stop Use

  • Stop use and ask a doctor if irritation, redness, or rash develops and persists for more than 3 days.
  • If swallowed, get medical help or contact a Poison Control Center right away.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. Do not inhale or ingest.

Dosage & Administration

Directions:
◊ Wet hands thoroughly with product                                                                                                                                                                         ◊ Rub hands together covering all surfaces until dry quickly without wiping                                                                                                             ◊ Not recommended for infants                                                                                                                                                                                   ◊ Use in children under 6 years of age must be supervised                                                                                                                                  Other Information:
◊ Do not store above 105 F or 39 C
◊ May discolor some fabrics, wood finishes and plastics

Inactive Ingredient

Inactive Ingredients: 
Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Carbomer, Aminomethyl Propanol, Hamamelis Virginiana (witchhazel) Leaf Extract, Fragrance

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