FDA Label for Mcclains Extra Strength And Moisture Hand Sanitizer Original
View Indications, Usage & Precautions
Mcclains Extra Strength And Moisture Hand Sanitizer Original Product Label
The following document was submitted to the FDA by the labeler of this product Mcclain's Health Llc. 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
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 CDC recommendations:
- Isopropyl Alcohol (75%, 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).
- Sterile distilled water or boiled cold water.
Formulation:
Active Ingredient(S)
Isopropyl 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
Do Not Use
- keep out of reach of children
- do not use in or near the eyes
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.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
USP Purified Water, Organic Aloe Leaf Juice, Phenoxyethanol, Glycerin, Withc Hazel Water, Alcohol, Carbomer, Triethanolamine, Tetrasodium Glutamate Diacetate, Essential Oils.
Recent Major Changes
- Changed usage to reflect exact wording on label.
- Added image of instructions to Dosage form
Package Label - Principal Display Panel
60 ml NDC: 81150-001-01
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