Otc - Active Ingredient
Lidocaine HCL 5%
Nerante Numbing Cream
FDA Label NDC 76986-032
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangdong Quadrant Ecological Technology Co., Ltd. for the product Nerante Numbing Cream (NDC 76986-032). 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, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, 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
Otc - Purpose
Local Anesthetic
Indications & Usage
For the temporary relief of local and anorectal itching and discomfort associated with anorectal disorders
For the temporary relief of pain, burning and soreness.
Warnings
For external use only.
Otc - Do Not Use
Do not use on broken or irritated skin.
Otc - When Using
Use only as much as recommended, unless a doctor advises otherwise.
Do not insert into the rectum with fingers or any mechanical device or applicator.
Otc - Stop Use
An allergic reaction is observed.
Symptoms such as redness, irritation, swelling, pain, orothers begin or worsen.
Does not show improvement within 7 days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
For adults and children 12 years and older: When practical, clean the area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth beforeapplying.
Apply up to 6 times daily.
Children under 12 years: Ask a doctor.
Inactive Ingredient
CETYL ALCOHOL
STEARYL ALCOHOL
GLYCERIN
MINERAL OIL
SODIUM POLYACRYLOYLDIMETHYL TAURATE
HYDROGENATED POLYDECENE
TRIDECETH-10
WATER
PROPYLENE GLYCOL
CETEARETH-25
STEARIC ACID
GLYCERYL STEARATE
DIMETHICONE
BENZYL ALCOHOL
PHENOXYETHANOL
BENZOIC ACID
ARNICA MONTANA FLOWER EXTRACT
TOCOPHERYL ACETATE
TRIETHANOLAMINE
EUCALYPTUS GLOBULUS LEAF OIL
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
LECITHIN
CARBOMER
EMU OIL
XANTHAN GUM
POTASSIUM LAURYL PHOSPHATE
DIPOTASSIUM PHOSPHATE
Package Label.Principal Display Panel
Label (Label)
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