Hand Sanitizer - Isopropyl Alcohol Antiseptic
FDA Label NDC 75161-101

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marek Hewryk Llc for the product Hand Sanitizer - Isopropyl Alcohol Antiseptic (NDC 75161-101). 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 active ingredient, purpose, use(s), warnings, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

ISOPROPYL ALCOHOL 75% W/V

Purpose

ANTISEPTIC

Use(S)

HAND SANITIZER TO HELP REDUCE BACTERIA THAT POTENTIALLY CAN CAUSE DISEASE. FOR USE WHEN SOAP AND WATER ARE NOT AVAILABLE.

Warnings

FOR EXTERNAL USE ONLY. FLAMMABLE. KEEP AWAY FROM HEAT OR FLAME.

DO NOT USE

  • IN CHILDREN LESS THAN 2 MONTHS OF AGE
  • ON OPEN SKIN WOUNDS

    • WHEN USING THIS PRODUCT KEEP OUT OF EYES, EARS, AND MOUTH. IN CASE OF CONTACT WITH EYES, RINSE EYES THOROUGHLY WITH WATER.

    STOP USE AND ASK A DOCTOR IF IRRITATION OR RASH OCCURS. THESE MAY BE SIGNS OF A SERIOUS CONDITION.

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.
  • SUPERVISE CHILDREN UNDER 6 YEARS OF AGE WHEN USING THIS PRODUCT TO AVOID SWALLOWING.

Other Information

  • STORE BETWEEN 15-30 C (59-86F)
  • AVOID FREEZING AND EXCESSIVE HEAT ABOVE 40C (104F)

Inactive Ingredients

GLYCERIN, HYDROGEN PEROXIDE, PURIFIED WATER USP, ALOE BARBADENSIS (ALOE VERA) LEAF JUICE, CARBOMER, TOCOPHERYL ACETATE (VIT. E), ANTHEMIS NOBILIS (CHAMOMILE) EXTRACT, TILIA CORDATA (LINDEN) EXTRACT, FRAGRANCE (PARFUM)

Package Label.Principal Display Panel

Hand-sanitizer-front-label (Hand Sanitizer Front Label)

Hand-sanitizer-front-label (Hand Sanitizer Front Label)

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