FDA Label for Sanitizer
View Indications, Usage & Precautions
Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Nutraze, S.c De R.l. De C.v.. 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
Alcohol 80% Purpose: Antiseptic
Inactive Ingredients
Glycerin, hydrogen peroxide, purifed water.
Use(S)
Hand Sanitizer Antiseptic solution to help reduce bateria that potentially can cause disease. For use when soap and water are not available.
Warnings
Flammable. Keep away from heat or flame.
Otc - Do Not Use
- In children less than 2 months of age
- In open skin wounds
Otc - When Using
Keep out of eyes, ears and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Otc - Purpose
Antiseptic
Otc - Stop Use
If irritation or rash occurs. These may be signs of a serious condition.
Otc - Ask Doctor
If irritation or rash occurs. These may be signs of a serious condition.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help, or contact a Poison Control Center right away.
Other Information
- Store between 15-30°C (59-86°F)
- Avoid freezing and excessive heat above 40°C (104°F)
Other
This is a hand sanitizer manufactured according to the Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (CoViD-19); Guidance for Industry.
The hand sanitizer is manufactured using only the following United States Pharmacopoeia (USP) grade ingredients in the preparation of the product (percentage in final product formulation) consistent with World Health Organization (WHO) recommendations:
1. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (80%, volume/volume (v/v)) in an aqueous solution denatured according to Alcohol and Tobacco Tax and Trade Bureau regulations in 27 CFR part 20.
2. Glycerol (1.45% v/v).
3. Hydrogen peroxide (0.125% v/v).
4. Sterile distilled water or boiled cold water.
The firm does not add other active or inactive ingredients. Different or additional ingredients may impact the quality and potency of the product.
Dosage & Administration
Topical
Principal Display Panel
500 mL NDC:77578-003-01
Package Label- Principal Display Panel
1000 L NDC: 77578-003-02
* Please review the disclaimer below.