FDA Label for Capsaicin Topical Analgesic
View Indications, Usage & Precautions
Capsaicin Topical Analgesic 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.
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Drug Facts
Manufactured for:
AvKARE, Pulaski, TN 38478
www.avkare.com
AV 06/22
Active Ingredient
Capsaicin 0.075%
Purpose
Topical Analgesic
Uses
temporarily relieves minor aches and pains of muscles and joints due to:
- simple backache
- arthritis
- strains
- sprains
Warnings
For external use only
Read all warnings and directions before use. TEST FIRST ON SMALL AREA OF SKIN.
Do Not Use
- on wounds or damaged skin
- if you are allergic to capsicum or chili peppers
- with heating pad
When Using This Product
- you may experience a burning sensation. The intensity of this reaction varies among individuals and may be severe. With regular use, this sensation generally disappears after several days.
- avoid contact with eyes, lips, nose and mucous membranes
- do not tightly wrap or bandage the treated area
- do not apply heat to the treated area immediately before or after use
Stop And Ask A Doctor If
- condition worsens or does not improve after regular use
- severe burning persists
- redness or blistering occurs
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
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
Other Information
Store at room temperature 15° - 30°C (59°F – 86°F).
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
Questions Or Comments?
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