Package Label.Principal Display Panel
Drug Facts
Deep Numbing Cream
FDA Label NDC 83364-023
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Yitongbada (shenzhen) International Trade Co., Ltd for the product Deep Numbing Cream (NDC 83364-023). 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 package label.principal display panel, otc - active ingredient, otc - purpose, indications & usage, otc - when using, otc - ask doctor, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Active ingredients
Menthol 10%
Otc - Purpose
Purpose
Topical Anesthetic
Indications & Usage
Uses
■ For the temporary relief of localized pain, itching, or discomfort from minor skin irritations.
Otc - When Using
When using this product
■ Avoid contact with eyes
■ Do not exceed the recommended daily dosage unless directed by a doctor.
■ Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Otc - Ask Doctor
Stop use and ask a doctor if
■ Condition worsens or does not improve within 7 days.
■ An allergic reaction occurs to ingredients in this product.
■ Redness, irritation, swelling, pain, or other symptoms develop or increase.
■ Symptoms clear up and occur again within a few days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of accidental ingestion, seek medical advice immediately or contact a Poison Control Center right away.
Otc - Pregnancy Or Breast Feeding
If pregnant or breastfeeding, ask a health professional before use.
Warnings
Warnings
For external use only
Dosage & Administration
Directions
■ When practical, cleanse the affected area with mild soap and warm water, then rinse thoroughly.
■ Gently dry by patting or blotting with toilet tissue or a soft cloth before applying.
■ Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
■ Children under 12 years of age: Consult a doctor.
Other Safety Information
Other information
■ Store at room temperature, away from heat and moisture.
■ ALWAYS CLOSE CAP TIGHTLY AFTER USE
Inactive Ingredient
Inactive ingredients
Aqua, Arnica Montana Flower Extract, Ethylhexyl Palmitate, Glycerin, Propylene Glycol, Cetearyl Alcohol, Emu Oil, Soy Lecithin, Butyrospermum Parkii (Shea Oil), Alpha-Tocopherol Acetate, Zanthoxylum Bungeanum Fruit Extract, Daphne Feddei Extract, Paeonol, Curcuma Longa (Turmeric) Fruit Extract, Salvia Miltiorrhiza Root Extract, Dendrobium Officinale Stem Extract, Stephania Tetrandra Extract, Aesculus Hippocastanum (Horse Chestnut) Extract, Glycyrrhiza Glabra (Licorice) Root Extract
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