Otc - Active Ingredient
Active Ingredient:
Ethyl Alcohol 62%
Anti-bacterial Hand Gel
FDA Label NDC 69358-0010
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Unigroup Wholesale Inc. for the product Anti-bacterial Hand Gel (NDC 69358-0010). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - stop use, otc - keep out of reach of children, dosage & administration, inactive ingredient, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose Antiseptic
Warnings
Warnings:For external use only.
Flammable. Keep away from fire or flame.
Otc - Stop Use
Stop use and ask for 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 doctor right away.
Dosage & Administration
Directions:
Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.
Inactive Ingredient
Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.
Storage And Handling
Other Information: Store below 118 F.
Indications & Usage
UseTo help reduce bacteria on the skin
Package Label.Principal Display Panel
Image Of Bottle Label (Label 41228)
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