Hand Sanitizer Gel
FDA Label NDC 68210-4082

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Spirit Pharmaceuticals Llc for the product Hand Sanitizer Gel (NDC 68210-4082). 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, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Ethyl alcohol 70%

Purpose

Antiseptic

Uses

• hand sanitizer to help reduce bacteria on the skin that potentially can cause disease
• recommend for repeated use

Warnings

For external use only. Flammable. Keep away from heat and flame.
Do not use • in children less than 2 months of age
                  • on open skin wounds
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When using this product
• keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
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Stop use and ask a doctor if irritation or rash appears and lasts. These may be signs of a serious condition.

Otc - Keep Out Of Reach Of Children

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

Directions

  •     Place enough product on hands to cover all surfaces. Rub hands together until dry.
  •    Children under 6 years of age should be supervised when using this product

Other Information

• Store between 15°-30°C (59°86°F)
• Avoid freezing and excessive heat above 40°C (104°F)
• may discolor certain fabrics or surfaces

Inactive Ingredients

benzalkinium chloride, fragrance, glycerin, hydrogen peroxide, isopropyl myristate, propylene glycol, tocopheryl acetate, water

Questions Or Comments?

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Other

Manufactured by: APL

P.O. Box 7771, Ajman, UAE

Under License From

MODD PERFUMES & COSMETICS

10 Cameron Road, Seven Kings

London, IG3 8LA

United Kingdom

For external use only

Made in U.A.E.

Distributed By:

Spirit Pharamceuticals LLC

Ronkonkoma, NY 11779

Principal Display Panel

HANDY

HAND-SANITIZER SOLUTION

EFFECTIVELY KILLS 99.9% OF THE

MOST COMMON GERMS/ BACTERIA

70%

ALCOHOL CONTENT

WITH

VITAMIN E & MOISTURIZERS

PLEASANT FRAGRANCE

STAY PROTECTED

16.9 FL. OZ. (500 ml)

MODD

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