FDA Label for Cinnamon Bark Sanitizer
View Indications, Usage & Precautions
Cinnamon Bark Sanitizer Product Label
The following document was submitted to the FDA by the labeler of this product Morning Star Aesthetics. 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 FDA recommendations: Classification of OTC Consumer Antiseptic Rub Active Ingredients in the 1994 TFM and in the 2016 Proposed Rule. Alcohol (ethanol) (USP or Food Chemical Codex (FCC) grade) (60-90%), volume/volume (v/v)) in an aqueous solution denatured
Active Ingredient(S)
Alcohol 75%(Gel) - 80% (Spray) v/v. Purpose: Antiseptic
Purpose
Antiseptic, Hand Sanitizer
Use
Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.
Warnings
For external use only. Flammable. Keep away from heat or flame
Do Not Use
- in children less than 2 months of age
- on open skin wounds
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.
- Supervise children under 6 years of age when using this product to avoid swallowing.
Other Information
- Store between 15-30C (59-86F)
- Avoid freezing and excessive heat above 40C (104F)
Inactive Ingredients
glycerin, hydrogen peroxide, purified water USP, Cinnamon Bark Essential Oil
Package Labels - Front And Rear
Essential Oil Sanitizer Spray Cinnamon Bark 4oz
(118 ml /4 fl oz) NDC: 80749-200-10
Essential Oil Hand Sanitizer Cinnamon Bark 1oz
(29.5 ml /1 fl oz.) NDC: 80749-200-20
Essential Oil Hand Sanitizer Cinnamon Bark 16oz
(473ml / 16 fl oz.) NDC: 80749-200-21
Sanitizer Rear Label
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