Otc - Active Ingredient
Capsaicin 0.1%
Capsaicin Cream
FDA Label NDC 73141-558
12 label sections · Submitted to the FDA by A2a Integrated Pharmaceuticals, Llc · 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - ask doctor, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic
Indications & Usage
Uses
Temporarily relieves minor aches and pains of muscles and joints due to
simple backache
arthritis
strains
sprains
Warnings
Warnings
For external use only
Read all warnings and directions before use. Test first on small area of skin.
Otc - Do Not Use
Do not use:
on wounds or damaged skin
if you are allergic to capsaicin or chili peppers
Otc - When Using
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 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.
Otc - Ask Doctor
Ask Doctor
Stop use and ask a doctor if:
condition worsens or does not improve after regular use
severe burning persists or blistering occurs.
Otc - Keep Out Of Reach Of Children
Keep out of Reach of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately
Dosage & Administration
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
Storage And Handling
Other Information: Store at room temperature 15°- 30°C (59° - 86°F)
Inactive Ingredient
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.
Otc - Questions
Questions or comments?
Call (800) 380-6709
Distributed By:
A2A Integrated Pharmaceuticals
Franklin, KY 42134
* Please review the disclaimer below.
