Otc - Active Ingredient
LIDOCAINE 5%
PHENYLEPHRINE 0.25%
Verdibliss Hemorrhoid Relief Ointments Ointment
FDA Label NDC 76986-034
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 Verdibliss Hemorrhoid Relief Ointments (NDC 76986-034). 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 - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Topical anesthetic
Vasoconstrictor
Indications & Usage
Temporarily relieves pain, itching, and burning.
Temporarily relieves swelling associated with hemorrhoids and other anorectal disorders.
Warnings
For external and/or rectal use only.
Otc - Do Not Use
Do not exceed the recommended dose.
Do not insert using fingers or devices other than as directed.
Otc - Ask Doctor
Ask a doctor before use if you have:
Some individuals may be allergic to the ingredients in this product.
Heart disease, high blood pressure,thyroid disease, or diabetes.. Difficulty urinating due to an enlarged prostate.
Are taking prescription drugs for high blood pressure or depression.
Otc - When Using
Avoid contact with eyes.
Otc - Stop Use
· if bleeding occurs, symptoms worsen, or do not improve within 7 days, or if signs of an allergic reaction develop.
· if you are pregnant or breastfeeding, consult your doctor before use.
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
· Cleanse and dry affected area before use.
· Children under 12 years: Consult a doctor before use.
· Apply up to 4 times daily.
· For rectal use: lubricate and insert as directed.
Inactive Ingredient
WATER
STEARYL ALCOHOL
ZINC OXIDE
GLYCERIN
MINERAL OIL
STEARIC ACID
CETEARETH-25
GLYCERYL STEARATE
CETYL ALCOHOL
DIMETHICONE
ARNICA MONTANA FLOWER EXTRACT
SODIUM POLYACRYLOYLDIMETHYL TAURATE
HYDROGENATED POLYDECENE
BENZYL ALCOHOL
PANTHENOL
LONICERA JAPONICA (HONEYSUCKLE) FLOWER EXTRACT
TRIETHANOLAMINE
PHENOXYETHANOL
EUCALYPTUS GLOBULUS LEAF OIL
POTASSIUM LAURYL PHOSPHATE
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER
OLEA EUROPAEA (OLIVE) FRUIT OIL
PETROLATUM
SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
XANTHAN GUM
ALOE BARBADENSIS LEAF JUICE POWDER
DIPOTASSIUM PHOSPHATE
TRIDECETH-10
BENZOIC ACID
Package Label.Principal Display Panel
Label (Label)
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