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.
Active Ingredient
Capsaicin 0.1%
Purpose
Topical Analgesic
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
- do not use with heating pad or expose area to sunlight
- 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 the eyes, lips, nose and mucous membranes
- do not tightly wrap or bandage the treatment area
- do not apply heat to the treated area immediately before or after use
When using this product:
Stop Use And Ask Doctor
Stope Use and Ask Doctor if:
- Condition worsens or does not improve after regular use
- severe burning persists
- redness or blistering occurs
Keep Out Of The Reach Of Children
Keep out of the reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Uses
Temporarily relieves minor aches and pains of muscles and joints due to:
- simple backache
- arthritis
- strains
- sprains
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
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
Questions? Comments?
1-855-361-3993
Manufactured for:
AvKARE, Pulaski, TN 38478
www.avkare.com
AV 06/22
Other Information
Store at room temperature 15°-30°F (59°-86°F)
Packaging
* Please review the disclaimer below.