Alcohol
FDA Label NDC 73418-043

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Hello Bello for the product Alcohol (NDC 73418-043). 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(s), purpose, use(s):, warnings:, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Otc - Do Not Use

  • Do not use: in children less than 2 months of age, on open skin wounds

Otc - When Using

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

Otc - Stop Use

  • Stop use and ask 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)

  • Avoid freezing and excessive heat above 40C (104F)

Inactive Ingredients:

glycerin, hydrogen peroxide, purified water USP

Principal Display Panel – 59 Ml Bottle Label

Non-sterile Solution

hello
bello™

Alcohol Antiseptic 80
Topical Solution

Hand Sanitizer
Spray

2 fl. oz. (59 ml) e

Principal Display Panel – 59 mL Bottle Label (Hel05 0000 01)

Principal Display Panel – 59 mL Bottle Label (Hel05 0000 01)

hello
bello™

Apple Blossom

62.5% Alcohol

Hand Sanitizer
Spray

2.0 fl. oz. (59 ml) e

Principal Display Panel – 59 mL Bottle Label (Hel05 0000 02)

Principal Display Panel – 59 mL Bottle Label (Hel05 0000 02)

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