FDA Label for Sanigenix Liquid Hand Sanitizer
View Indications, Usage & Precautions
Sanigenix Liquid Hand Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Cbio Brand Distribution International Inc.. 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.
- 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)
Ethyl Alcohol 80% v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
To help reduce bacteria on skin.
Warnings
For external use only. Flammable, keep away from source of heat & fire.
Otc - When Using
When using this product, avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use & ask doctor if irritation or rash occurs or redness develops & persists.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical help and contact a Poison Control Center Immediately.
Directions
Put enough hand sanitizer on your palm to cover hands & rub hands together until dry. Children under 5 should be supervised using this product.
Inactive Ingredients
Water (Aqua, Eau), Hydrogen Peroxide
Recent Major Changes
Section 4:
To help reduce bacteria on skin.
Section 9:
Put enough hand sanitizer on your palm to cover hands & rub hands together until dry.
Children under 5 should be supervised using this product.
Package Label - Principal Display Panel
1 GALLON (3.785L) NDC: 78044-300-04
55 GALLON (208.198L) NDC: 78044-300-05
265 GALLON (1003.13L) NDC: 78044-300-06
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