Otc - Active Ingredient
Purpose
Lidocaine 5%........Topical Analgesic
Gniby Lidocaine Anorectal Hemorrhoidal Numbing Cream
FDA Label NDC 87152-003
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 Numbing (NDC 87152-003). 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, dosage & administration, indications & usage, inactive ingredient, 87152-002-01-50g, 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 onlyAvoid contact with the eyes
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.
Indications & Usage
1.First, conduct apatch test to checkfor skin suitabilityand effectiveness.
2.Thoroughly washyour hands and thetreatment area withmild soap and warmwater, then dry.
3.Apply a THICKlayer of cream tocover the entiretreatment area andits surroundings.
Inactive Ingredient
Inactive ingredients
Water, Propylene Glycol,Carbomer, Glycerin,Disodium Edta,Hydroxyacetophenone,1,2-Hexanediol, MenthaArvensis Leaf Extract.Chrysanthellum IndicumExtract, PortulacaOleracea Extract,Peg-40 HydrogenatedCastor Oil
87152-002-01-50G
87152-002-01-50g (87152 002 01 50g)
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