The following Structured Product Label (SPL) was submitted to the FDA by Shengnan (guangzhou) Cosmetics Co., Ltd for the product Oeahfc Numbing Cream (NDC 84019-049). 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 warnings, otc - purpose, otc - stop use, otc - active ingredient, otc - when using, inactive ingredient, dosage & administration, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Warnings: For external use only. Avoid contact with the eyes.
Do not use: If Pregnant or breastfeeding, ask a health professional before use. In case of accidental ingestion, get medical help or contact the Poison Control Center immediately. Seal is broken or missing.
Purpose: Topical Analgesic
Stop use and ask a doctor if redness, irritation, swelling, pain, or other symptoms occur, or if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.
Active Ingredient
8% Menthol
When using this product Do not exceed the recommended daily dosage unless directed by a doctor. Certain persons can develop allergic reactions to the ingredients in this product. Do not put this product into the rectum by using fingers.
Inactive Ingredients:
Water, Propylene Glycol, Glycerin, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Emu Oil, Allantoin, Tocopherol, Carbomer, Triethanolamine, Phenoxyethanol, Ethylhexylglycerin.
How To Use It Correctly?
1.Clean hands and treatment area with mild soap and warm water and rinse thoroughly and dry.
2.Apply a thick layer of numbing cream to the treatment area, making sure to cover both the treatment area and its surroundings.
3.Wrap tightly with plastic wrap and wait 40-60 minutes (Longer time, better effect).
4.Remove the plastic wrap and wait another 15-25 minutes for the numbness to peak.
5.Begin the procedure. Directions
Adults: Clean the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting with toilet tissue or a soft cloth before application of this product. Children under 12 years of age: consult a doctor.
Use
For the temporary alleviation of localized discomfort, pruritus, pain, or burning sensation in the perianal area associated with anorectal disorders.
Keep out of reach of children In case of accidental ingestion, seek medical help immediately.
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