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Drug Facts
Manufactured for:
AvKARE, Pulaski, TN 38478
www.avkare.com
AV 06/22
Capsaicin Cream
FDA Label NDC 50268-196
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avpak for the product Capsaicin (NDC 50268-196). 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 other, active ingredient, purpose, uses, warnings, do not use, when using this product, stop and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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