Active Ingredient
Capsaicin 0.1%
Tunyll Capsaicin Cream
FDA Label NDC 87298-068
10 label sections · Submitted to the FDA by Guangzhou Hechuang Commercial Service Co.,ltd. · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Guangzhou Hechuang Commercial Service Co.,ltd. for the product Tunyll Capsaicin Cream (NDC 87298-068). 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 active ingredient, purpose, uses, warnings, stop use and ask a doctor if, keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Topical analgesic
Uses
For the temporary relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, strains, sprains and bruises.
Warnings
Warnings
For external use only.
Do not use
●on wounds or damaged skin
●in anyone under 18 years of age
When using this product
●avoid contact with eyes and mucous membranes
●do not bandage tightly or use with a heating pad
●do not apply other topical pain relievers to the same area
●keep the treated area away from heat and direct sunlightd
●a burning sensation may occur
Stop Use And Ask A Doctor If
●the condition gets worse
●symptoms last more than 7 days, or clear up and return within a few days
●severe burning, irritation or redness occurs
●pain, swelling or blistering develops at the application site
If pregnant or breast-feeding, ask a health professional before use.
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.
Directions
Directions
Adults 18 years of age and older:
●apply a thin layer to the affected area and massage gently until absorbed
●use as needed, no more than 3 to 4 times daily
●wash hands thoroughly with soap and water after use
Children and adolescents under 18 years of age: do not use.
Other Information
Other information
●store at 20°-25°C (68°-77°F)
●protect from excessive heat and direct sunlight
●keep container tightly closed
●do not freeze
Inactive Ingredients
Aloe barbadensis leaf juice, Arnica montana flower extract, butylene glycol, Butyrospermum parkii (shea) butter, caprylic/capric triglyceride, carbomer, cetearyl alcohol, Chamomilla recutita (matricaria) flower extract, dimethicone, disodium EDTA, ethylhexylglycerin, glycerin, glyceryl stearate, menthyl lactate, niacinamide, panthenol, PEG-100 stearate, phenoxyethanol, purified water, sodium hydroxide, tocopheryl acetate.
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