Active Ingredients
Lidocaine 5%
Phenylephrine HCl .25%
Lidocaine Phenylephrine Spray
FDA Label NDC 73581-910
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yyba Corp for the product Lidocaine Phenylephrine (NDC 73581-910). 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 active ingredients, purpose, use, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local anesthetic
Vasoconstrictor
Use
temporarily reduces swelling associated with irritated hemorrhoidal tissue and other anorectal disorders
Warnings
For external use only.
When Using This Product
- avoid contact with eyes
- do not exceed recommended dosage unless directed by a doctor
- do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use And Ask A Doctor If
- rectal bleeding occurs
- treated symptom does not subside or redness, irritation, swelling, pain, or other symptoms develop or increase
If Pregnant Or Breastfeeding
ask a health professional before use
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away
Directions
- when practical, cleanse the affected area with mild soap and warm water
- rinse thoroughly and gently pat dry
- spray affected area
- wash hands after applying
- replace cap after use
- apply externally to affected area not more than 4 times daily
- do not use, ask a doctor
Adults and children 12 years or older:
Children under 12 years of age:
Other Information
Store out of direct sunlight, in a cool dry, well-ventilated area. Do not store at temperature above 120 degrees farenheit (49 degrees celsius)
Inactive Ingredients
Aloe Barbadensis Leaf Juice, Citric Acid, Disodium EDTA, DL-Panthenol, Glycerin, Isopropyl Myristate, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Polysorbate 20, Propylene Glycol, Purified Water.
Questions Or Comments?
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Package Label.Principal Display Panel
Label (Lidophenlabel)
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