Otc - Active Ingredient
Lidocaine 5%-----..-Topical Analgesic
Gniby - Lidocaine Anorectal Hemorrhoidal Cream
FDA Label NDC 87152-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Putian Licheng District Zhijiancheng Trading Co., Ltd. for the product Gniby - Lidocaine Anorectal Hemorrhoidal (NDC 87152-002). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, warnings, inactive ingredient, indications & usage, dosage & administration, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses
For the temporary relief of localitching and discomfort associatedwith anorectal disorders.For the temporary relief of pain,burning and soreness.
Otc - Keep Out Of Reach Of Children
Keep Out Of Reach Of ChildrenIf swallowed, get medical help orcontact a poison control center rightaway.
Warnings
Warnings.
For external use only·Avoid contact with the eyes
Inactive Ingredient
Water
PROPYLENE GLYCOL
CARBOMER
GLYCERIN
DISODIUM EDTA
HYDROXYACETOPHENONE
1,2-HEXANEDIOL
MENTHA ARVENSIS LEAF EXTRACT
CHRYSANTHELLUM INDICUM EXTRACT
PORTULACA OLERACEA EXTRACT
PEG-40 HYDROGENATED CASTOR OIL
Indications & Usage
Condition worsens or does notimprove within 7 days.Allergic reaction occurs toingredients in this product.Symptom being treated does notsubside or if redness, irritationIf pregnant or breast-feeding,aska health professional before use.
Dosage & Administration
Children under 2 years: Do not use.For children under 12: Consult adoctor.
For adults: Apply to affected area notmore than 6 times daily. Clean theaffected area with mild soap andwarm water, making sure to rinsethoroughly. Gently dry the area withtoilet tissue or a soft cloth beforeapplying the product.
Package Label.Principal Display Panel
Labeling (87152 002 01 50g)
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