Antiseptic Hand Sanitizer
FDA Label NDC 79302-302

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Jouan Co., Ltd. for the product Antiseptic Hand Sanitizer (NDC 79302-302). 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 75% v/v

Purpose

Antiseptic

Uses

  • hand sanitizer to reduce bacteria on the skin
  • recommended for repeated use
  • for use when soap and water are not available

Warnings

Flammable. Keep away from fire/flame

For external use only

Do not use

  • on children under 2 months of age
  • on open skin wounds

    • When using this product • do not use in or near eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Apply sufficient amount and spread evenly over entire hands. Rub repeatly until dry without wiping.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other Information

  • store between 15-30°C (59-86° F)
  • avoid freezing and excessive heat above 40°C (104°F)

Inactive Ingredients

glycerin, aloe vera gel, vitamin E, lemon oil, water

Questions?

+1-302-509-8362

You may also report serious side effects to this phone number.

Mon-Fri 9:00 AM - 5:00 PM EST

Other

Sanitizing Moisturizing

Effective Disinfection

Vitamin E, Aloe Vera, Moisturizing, Nourishing

SAFE, NON-TOXIC, CONVENIENT, EFFECTIVE

Manufactured by: JOUAN CO LTD, 4F., No 10, Ln. 218, Sec. 2, Zhongxing Rd., Xindian Dist., New Taipei City, Taiwan (R.O.C), 23146

Product of Taiwan

Waived for general skincare product.

Shelf life: 5 years

This product is manufactured by Jouan Co., Ltd.
certified by the international GMP ISO22716

Packaging

Untitled (79302 302)

Untitled (79302 302)

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