Antiseptic Hand Sanitizer
FDA Label NDC 61429-005

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Miraclecorp Products for the product Antiseptic Hand Sanitizer (NDC 61429-005). 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[s], purpose, use[s], warnings, do not use, otc - when using, 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[S]

Alcohol 80% v/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 wound

Otc - When Using

When using this product keep out of eyes, ears and mouth. In case of contact with eyes, rinse throughly with water.

Otc - Stop Use

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

  • Store between 15-30C (59-86F)

Inactive Ingredients

Hydrogen Peroxide, Glycerol, Distilled Water

Principal Display Panel - 103.5 Ml Bottle Label

Alcohol Antiseptic 80%
Topical Solution

Antiseptic
Hand Sanitizer
Non-Sterile Solution

Made in Dayton, Ohio by Your Friends at

Buckeye™
VODKA

buckeyevodka.com

MiracleCorp
Premium Pet Products
miraclecorp.com

3.5 fl oz | 103.5 ml

DO NOT STORE ABOVE 86F
SAMPLE - NOT FOR SALE
NOT FOR CONSUMPTION

238910_041320

Principal Display Panel (103.5 ml Bottle Label)

Principal Display Panel (103.5 ml Bottle Label)

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