Active Ingredient
Capsaicin 0.1%
Capsaicin Cream
FDA Label NDC 73141-558
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by A2a Integrated Pharmaceuticals, Llc for the product Capsaicin Cream (NDC 73141-558). 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, ask doctor, 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
External 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 capsaicin or chili peppers
- 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 treated area
- do not apply heat to the treated area immediately before or after use.
When using this product:
Ask Doctor
Stop use and ask a doctor if:
- condition worsens or does not improve after regular use
- severe burning persists or blistering occurs.
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
Directions
Adults and children 18 years of age and older:
- apply a thin film of cream to affected area and gently tub 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
Other Information: Store at room temperature 15°- 30°C (59° - 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
Questions or comments?
Call (800) 380-6709
Distributed By:
A2A Integrated Pharmaceuticals
Bowling Green, KY 42101
Package Label.Principal Display Panel
NDC 73141-558-02
A2A Integrated Pharmaceuticals
Capsaicin Cream 0.1%
External Analgesic
NET WT. 2.1 oz. (60g)
* Please review the disclaimer below.
