FDA Label for Hand Sanitizer

View Indications, Usage & Precautions

Hand Sanitizer Product Label

The following document was submitted to the FDA by the labeler of this product Biominerales Pharma, Llc. 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.

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DRUG FACTS

Manufactured for and
Distributed by:

Biominerales Pharma, LLC
Boca Raton, Florida 33442


Active Ingredient



Ethyl alcohol 70% v/v


Purpose



Antiseptic


Inactive Ingredients



Carbomer, Glycerin, Propylene Glycol, Aminomethyl Propanol, Isopropyl Myristate, Tocopheryl Acetate, Purified Water, Fragrance.


Use (S)



Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when water and soap 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 or on open skin wounds.


Otc - When Using



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

Principal Display Panel - 3,785 Ml Bottle Label



BIOMINERALES
PHARMA

HAND SANITIZER - GEL

Kills more than 99.99% of germs

Prevention:
Keep away from heat / sparks / open flames / hot surfaces.
No Smoking. Keep container tightly closed.
Response:
IF IN EYES: Rinse cautiously with water for several minutes.
Remove contact lenses, if present and easy to do. Continue rinsing.
If eye irritation persists: Get medical advice / attention. In case of fire:
Use dry sand, dry chemical or alcohol - resistant foam for extinction.
Storage:
Store in a well-ventilated place. Keep cool. Store Between
15-30 °C (59 - 86 °F). Avoid freezing and excessive heat above
40 °C (104 °F)
Disposal:
Dispose of contents / container to an approved waste disposal plant.

Active Ingredients: Ethyl Alcohol 70% v/v

NDC: 77110-270-01

Manufactured for and
Distributed by:
Biominerales Pharma, LLC
Boca Raton, Florida 33442
www.biomineralespharma.com

Net Contents
1 Gal. (3,785 mL)


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