Hand Sanitizer
FDA Label NDC 70338-604

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medzone Products, Llc for the product Hand Sanitizer (NDC 70338-604). 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, stop use and ask a doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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DRUG FACTS

DISTRIBUTED BY
MedZone Products LLC
9300 Marshall Dr, Ste. 200,
Lenexa, Kansas 66215 USA

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 age | On open skin wounds

When Using This Product

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

Stop Use And Ask A Doctor

If irritation or rash occurs. 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 | Supervise children under 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 15-30°C (59-86°F) | Avoid freezing and excessive heat above 40°C (104°F)

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 - 473 Ml Bottle Label

MedZone®
SINCE 2001

Hand
Sanitizer

GEL

MADE IN USA

  • ANTISEPTIC HANDWASH
  • DAILY USE, TRAVEL,
    & SPORTS
  • RINSE FREE

    • OF COMMON ILLNESS CAUSING GERMS
    KILLS
    99.99%
    IN 15 SECONDS

    16 FL OZ (473mL)

    Principal Display Panel (473 mL Bottle Label)

    Principal Display Panel (473 mL Bottle Label)

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