FDA Label for Alcohol

View Indications, Usage & Precautions

Alcohol Product Label

The following document was submitted to the FDA by the labeler of this product Hello Bello. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

hello
bello™

Apple Blossom

62.5% Alcohol

Hand Sanitizer
Spray

2.0 fl. oz. (59 ml) e


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