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 Gaza Proveedora De Servicios De Hospedaje Y Alimentacion. 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.
Other
This is a rub hand sanitizer (leave in product) which is intended to be used when soap and water are not available, and are left on and not rinsed off with water. It complies with the final rule on consumer antiseptic rubs, using alcohol in a percentage between 65 and 90%. The product is made with
- Alcohol (ethanol) (70%, volume/volume (v/v)) in an aqueous solution denatured.
- Glycerol (10% v/v).
- Isopropyl alcohol (1.33% v/v).
- Sterile distilled water or boiled cold water.
- Carbomer 940 (0.25% m/v)
- Polysorbate 20 (3.33% m/v)
The firm add only fragrance (0.002%) as an inactive ingredient, and realizes it may impact the quality and potency of the product.
Active Ingredient(S)
Alcohol 70% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
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 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.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, isopropyl alcohol, carbopol 940, polysorbate 20, fragrance, purified water USP
Package Label - Principal Display Panel
1000 mL NDC: 76540-100-01
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