FDA Label for Agachy Fast Clean Hand Sanitizer
View Indications, Usage & Precautions
Agachy Fast Clean Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Icomax Co., Ltd.. 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 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:
- 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.
- Glycerol (1.45% v/v).
- Hydrogen peroxide (0.125% v/v).
- 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.
Active Ingredient(S)
Alcohol 75% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria on the skin.
Warnings
For external use only. Flammable. Keep away from heat or flame.
Otc - When Using
When using this product do not use in or near the eye. In case of contact with eyes, rinse thoroughly with water.
Otc - Stop Use
Stop use and ask a doctor if irritation or rash appears and lasts.
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 your palm to cover all surfaces and rub hands together until dry.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Avoid freezing and excessive heat above 40C (104F)
- May discolor certain fabrics or surface
Inactive Ingredients
Water, Butylene Glycol, Glycerin, Carbomer, Triethanolamine, Menthol, Aloe Barbadensis Leaf, Sodium Hyaluronate, 1,2-Hexanediol
Package Label - Principal Display Panel
500 mL NDC: 77201-002-50
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