Otc - Active Ingredient
Lidocaine 5.0%
Witch Hazel 10.0%
Ravyndra Lidocaine 5% Numbing Cream
FDA Label NDC 87681-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Xinhongda Trading Service Co., Ltd. for the product Ravyndra Lidocaine 5% Numbing Cream (NDC 87681-004). 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 - stop use, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Local anesthetic
Astringent
Indications & Usage
For the temporary relief of pain, soreness, burning, itching,and discomfort associated with hemorrhoids.
Warnings
For external use only.
Otc - Do Not Use
Do not put this product into the rectum by using fingers or any mechanical device or applicator. If condition worsens or does not improve within 7 days, consult a doctor.
Do not exceed the recommended daily dosage unless directed by a doctor. In case of bleeding, consult a doctor promptly.
Otc - Stop Use
Certain persons can develop allergic reactions to ingredients in this product. If the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase, discontinue use and consult a doctor.
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
Adults: When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Apply externally to the affected area up to 3 times daily or after each bowel movement Children under 12 years of age: consult a doctor.
Inactive Ingredient
WATER
PROPYLENE GLYCOL
HYDROGENATED POLYDECENE
GLYCERIN
CETEARYL ALCOHOL
CAPRYLIC/CAPRIC TRIGLYCERIDE
GLYCERYL STEARATE
PEG-100 STEARATE
DIMETHICONE
ALOE BARBADENSIS LEAF JUICE
PHENOXYETHANOL
LECITHIN
CARBOMER
ALLANTOIN
TOCOPHERYL ACETATE
ETHYLHEXYLGLYCERIN
TRIETHANOLAMINE
DISODIUM EDTA
BOSWELLIA CARTERI OIL
CALENDULA OFFICINALIS FLOWER EXTRACT
GINKGO BILOBA EXTRACT
Package Label.Principal Display Panel
Label (Label)
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