Otc - Active Ingredient
Capsaicin 0.1% w/w – External Analgesic
The following Structured Product Label (SPL) was submitted to the FDA by Danous Land Floow Llc for the product Dr. Luke Capsaicin Cream (NDC 87147-003). 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 - when using, otc - do not use, otc - keep out of reach of children, otc - pregnancy or breast feeding, warnings, inactive ingredient, instructions for use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Capsaicin 0.1% w/w – External Analgesic
■ use only as directed ■ do not apply to wounds, broken or irritated skin ■ avoid contact with eyes or mucous membranes ■ a burning, stinging or warming sensation may occur upon application and generally lessens with continued use; if severe burning occurs, discontinue use ■ do not bandage tightly ■ do not use with a heating pad or right after bathing/shower ■ do not expose the treated area to heat or direct sunlight ■ do not use at the same time as other topical analgesics
■ condition worsens ■ symptoms persist for more than 7 days or clear up and occur again within a few days ■ excessive irritation/redness, swelling, blistering or signs of skin injury develop
If swallowed, get medical help or contact a Poison Control Center right away.
ask a health professional before use.
For external use only
Test first on a small area of skin.
Purified Water, Glycerin, 1,3-Propanediol, Carbomer, Aminomethyl Propanol (pH adjuster), Menthyl Lactate, Panthenol, Bisabolol, Allantoin, PEG-40 Hydrogenated Castor Oil, Phenoxyethanol, Ethylhexylglycerin.
Adults:
apply a thin layer to affected area and massage until absorbed; repeat up to 3–4 times daily as needed.
Wash hands with soap and water immediately after applying.
Children under 18 years:
ask a doctor.
For sensitive skin, start once daily for 2–3 days, then increase as tolerated.
For the temporary relief of minor aches and pains of muscles and joints associated with: ■ arthritis ■ simple backache ■ strains ■ sprains ■ bruises
Apply to affected area not more than 3–4 times daily.
Topical analgesic
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