Active Ingredient:
Lidocaine HCl 5.0%
Lidocaine Gel
FDA Label NDC 73581-115
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 (NDC 73581-115). 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 ingredient:, purpose, uses:, warnings:, otc - when using, otc - stop use, otc - pregnancy or breast feeding, otc - 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
Anorectal (hemorrhoidal) cream
Uses:
helps relieve pain, itching, and burning associated with hemorrhoids and other anorectal disorders
Warnings:
For external use only
___________________
Do not use
- on large areas of the body or on cut, irritated or swollen skin
- on puncture wounds
- for more than one week without consulting a doctor
Otc - When Using
When using this product
- use only as directed. Read and follow all directions and warnings on this carton
- do not allow contact with the eyes and mucous membranes
- do not bandage or apply local heat (such as heating pads) to the area of use
Otc - Stop Use
Stop use and ask a doctor if
- condition worsens
- skin reactions occur, such as rash, itching, redness, irritation, pain, and swelling
- symptoms persist for more than 7 days or clear up and occur again within a few days
- keep away from fire or flame
Flammable
Otc - Pregnancy Or Breast Feeding
If pregnant or breast feeding
- ask a health professional before use
Otc - Keep Out Of Reach Of Children
Keep out of reach of children and pets
If swallowed, get medical help or contact a Poison Control Center right away at 1-800-222-1222.
Directions
Adults and children over 12 years: apply a thin layer to affected area every 6 to 8 hours, not to exceed 3 applications in a 24 hour period
Children 12 years and younger: ask a doctor
Inactive Ingredients
Alcohol Denat., Aloe Barbadensis Leaf Juice, Carbomer, Chondroitin, Citric Acid, Dimethyl Sulfone, Ethylhexylglycerin, Glycerin, Hydrogen Sulfate, Phenoxyethanol, Polysorbate 20, Potassium Hydroxide, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Triethanolamine, Water
* Please review the disclaimer below.
