FDA Label for Capsaicin
View Indications, Usage & Precautions
Capsaicin Product Label
The following document was submitted to the FDA by the labeler of this product Avpak. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active Ingredient: Capsaicin 0.1%
Otc - Purpose
Purpose: Topical Analgesic
Indications & Usage
Uses: Provides penetrating pain relief. Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.
Warnings
Warnings: For external use only.
Do not use:
- on wounds or damaged skin
- if you are allergic to capsicum or chili peppers
- with heating pad
- you may experience a burning sensation The intensity of this reaction varies among individuals and may be severe. With regular use, the sensation generally disappears after several days.
- avoid contact with the eyes, lips, nose and mucous membranes
- do not tightly wrap or bandage the treatement area
- do not apply heat, or direct sunlight to the treated area immediately before or after use
- condition worsens or does not improve after regular use
- severe burning persists
- redness or blistering occurs
When using this produce:
Stop use and ask a doctor if:
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions – Adults and children 18 years of age and older
- apply a thin film of cream to affected area and gently rub in until fully absorbed
- unless treating hands, wash hands thoroughly with soap and water immediately after application
- for best results, apply 3 to 4 times daily
Children under 18 years: ask a doctor.
Storage And Handling
Other Information:store at room temperature 15° - 30°C (59° - 86°F)
Inactive Ingredient
Inactive Ingredients: Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum
Other
Questions? Comments?
1-855-361-3993
Manufactured for:
AvKARE, Pulaski, TN 38478
www.avkare.com
AV 06/22
Packaging
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