Drug Facts
Alcohol 70% v/v - Antiseptic
Theorie Anti-microbial Instant Hand Sanitizer
FDA Label NDC 73857-001
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dynastis, Llc for the product Theorie Anti-microbial Instant Hand Sanitizer (NDC 73857-001). 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 drug facts, uses:, warnings:, otc - keep out of reach of children, do not use:, otc - when using, indications & usage, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses:
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.
If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
KEEP OUT OF REACH OF CHILDREN SECTION
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. Children must be supervised when using this product.
Indications & Usage
Stop use and ask a doctor if: irritation or rash occurs. These maybe signs of a serious condition.
Directions:
Place one pump quantity of the product in you palm and rub your hands entirely until product is completely absorbed and dry. Children must be supervised when using this product.
Inactive Ingredients:
Water, Glycerin, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol, Sodium Hyaluronate, Argania Spinosa Kernel (Argan) Oil, Tocopheryl Acetate, Phenoxyethanol, Ethylhexylglycerin, Fragrance.
Other Information:
Store at room temperature 68°F to 77°F (20° to 25°C)
Do not expose to excessive heat.
You may report a serious adverse reaction to: Hautehouse, LLC, 909 NW Terrace, Fort Lauderdale, FL 33311 USA
For Questions:
HAUTEHOUSE INC.
909 NW Terrace
Fort Lauderdale, FL 33311 USA
+1 (954) 376-8966
www.hautehouse.com
Package Label.Principal Display Panel
Theorie Tube Label (Theorie.hand.sanitizer.ethoh)
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