Otc - Active Ingredient
CAPSAICIN 0.1%
Nerocare Capsaicin Neuropathy Relief Cream
FDA Label NDC 84066-108
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 Tata Biotechnology Co., Ltd. for the product Nerocare Capsaicin Neuropathy Relief Cream (NDC 84066-108). 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 - pregnancy or breast feeding, otc - keep out of reach of children, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
EXTERNAL ANALGESIC
Indications & Usage
Effectively alleviatelocal neuralgia
Warnings
For external use only.
Otc - Do Not Use
Do not use in or contact with eyes.
Do not apply to wounds or damagedskin.
Otc - Pregnancy Or Breast Feeding
Do not use it if pregnant or breastfeeding.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children unless under adult supervision.
lf swallowed, get medical help or contact a Poison Control Center right away.
Inactive Ingredient
INACTIVE INGREDIENTS:
GLYCERIN, WATER, MINERAL OIL, BUTYROSPERMUM PARKII (SHEA) BUTTER, DIMETHICONE, CETEARYL ALCOHOL, GLYCERYL STEARATE, PHENOXYETHANOL, PEG-100 STEARATE, POLYACRYLAMIDE, METHYLPARABEN, C13-14 ISOPARAFIN, MENTHYL LACTATE, BHT, ALLANTOIN, DIMETHICONOL, LAURETH-7, FRAGRANCE, DISODIUM EDTA, XANTHAN GUM, BUTYLENE GLYCOL, ARNICA MONTANA FLOWER EXTRACT, 1,2-HEXANEDIOL, HYDROXYACETOPHENONE
Dosage & Administration
Directions:
1.Clean and dry skin.
2.Apply an appropriate amount evenly toaffected areas such as your back,neck,knees,hips,shoulders and elbows,
3.Massage gently until absorbed.
4.Allow the area to dry naturally after application
5.Apply a small amount of the product tothe affected area 2-3 times daily.
Other Safety Information
Storage:
1.Please seal the product and store it in acool,dry place away from direct sunlight,
2.Do not store it in damp or high,temperatureenvironments like bathrooms,kitchens,or refrigerators.
3.Keep it out of children's reach,lftheproduct changes in characteristics(eg:oil separation or abnormal odor)discontinue use.
Otc - Questions
Email:[email protected]
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