Hand Sanitizer
FDA Label NDC 74318-100

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nuance Medical, Llc for the product Hand Sanitizer (NDC 74318-100). 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 other, active ingredient, purposes, uses, warnings, do not use, when using this product, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Ethyl Alcohol 62.5% v/v

Purposes

Antiseptic handwash

Uses

for handwashing to decrease bacteria on the skin

Warnings

  • For external use only
  • Flammable, keep away from fire or flame, heat, sparks, and sources of static discharge

Do Not Use

  • In eyes| In children less than 2 months of ag| on open skin wounds

When Using This Product

  • If in eyes, rinse promptly and thoroughly with water
  • Discontinue use if irritation and redness develops

Otc - Stop Use

Stop use and ask a doctor if skin irritation or redness occurs or 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

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children 6 years of age when using this product to avoid swallowing

Other Information

  • For additional information, see Safety Data Sheets (SDS)
  • For emergency medical information in USA and Canada, call 1-888-255-3924
  • For emergency medical information worldwide, call 1-813-248-0573
  • Store between 15-30C (59-86F) | Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients

water (aqua), propylene glycol, dimethicone PEG-7 Isostearate, acrylates/ C10-30 Alkyl Acrylate Crosspolymer, aminomethylpropanediol, tocopherol acetate, aloe barbadensis leaf juice

Principal Display Panel - 177.4 Ml Bottle Label

Nuance Medical®

HAND SANITIZER
GEL

ANTISEPTIC | RINSE-FREE | 62.5% ALCOHOL

FOR HANDS
Dye Free, Fragrance Free

Kills 99.99% of germs and
Bacteria in just 15 seconds

6 fl. oz. (177.4 ml)

Made in USA

Item # G180060

Principal Display Panel (177.4 ml Bottle Label)

Principal Display Panel (177.4 ml Bottle Label)

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