Active Ingredient
Lidocaine Hcl 5%
Phenylephrine Hcl 0.25%
Lidocaine
FDA Label NDC 83365-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sichuan Gumo Brand Management Co.,ltd for the product Lidocaine (NDC 83365-002). 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, do not use, when using, stop use, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Local Anesthetic
Vasoconstrictor
Uses
For the temporary relief of local and anorectal itching , discomfortand pain associated with anorectal disorder or anorectal inflammation.
Warnings
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
Do Not Use
Do not use this product if :
pregnant or breastfeeding, ask a health professional before use.
tamper-evident " Do not se this product if seal is broken or missing.
you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of prostate gland unless directed by a doctor.
When Using
When using this product
do not exceed the recommended the daily usage.
certain persons can develop allergic reactions to ingredients in this product.
do nut put this product into the rectum by using finger or any medical device or applicator.
If swallowed, call your Poison Control Center immediately. If condition worsens or does not improve within 7 days, consult a doctor
Stop Use
Stop use and ask a doctor if
The symptom being treated does not subside, or if redness, irritation, swelling, pain, or other symptoms develop or increase.
Directions
Cleanse the affected area.
Sensitivity and possible allergy tests advised prior to use Spray sparingly to affected area after thoroughly cleansing. Wait until anesthetic effect occurs . You may reapply to continue numbing effect.
apply to the affected area up to 4 times daily.
children under 12 years of age: consult a doctor.
Other Information
Keep away from direct sunlight or heat.
store in room temperature (59-86F/15-30C)
Inactive Ingredients
Allantoin, Arginline, Benzyl Alcohol, Disodium EDTA , Ethoxydiglycol, Phenoxyethanol, Polysorbate 20, Purified Water, Sodium Benzoate, Sodium Sulfite
Keep Out Of
Keep Out Of Reach Of Children If Swallowed .Get Medical Help Or Contact A Poison Control Center Right Away
Package Label.Principal Display Panel
83365-001-01 (83365 001 01)
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