FDA Label for Antiseptic Hand Sanitizer

View Indications, Usage & Precautions

Antiseptic Hand Sanitizer Product Label

The following document was submitted to the FDA by the labeler of this product Jouan Co., Ltd.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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




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