Other
CAPSICUM PATCH
Capsicum Patch
FDA Label NDC 81484-701
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Anhui Miao De Tang Pharmaceutical Co., Ltd. for the product Capsicum Patch (NDC 81484-701). 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, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Camphor 9.6%
Capsicum extract as Capsaicin 0.25%
Menthol 7.8%
Otc - Purpose
For the temporary minor aches and pains of muscles and joints associated with:
· arthritis
· simple backache
· strains
· bruises
Indications & Usage
For the temporary minor aches and pains of muscles and joints associated with:
arthritis
simple backache
strains
bruises
TOPICAL ANALGESIC
Warnings
For external use only
When using this product
avoid contact with the eyes
do not apply to wounds or damaged skin
do not bandage tightly
use only as directed
avoid contact with the eyes, mucous membranes, or rashes
Otc - Do Not Use
Stop use and ask a doctor if
rash, itching, or excessive skin irritation develops
conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
Otc - When Using
lf pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children. if swallowed, get medical help or contact a Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if
rash, itching, or excessive skin irritation develops
conditions worsen
symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Storage And Handling
avoid storing products in direct sunlight.
protect products from excessive moisture.
Inactive Ingredient
lanolin, lithopone, paraffin, resin, rosin, vaseline
Dosage & Administration
Adults and children 12 years of age and older:
clean and dry the affected area.
remove the patch from the film.
apply to affected area not more than 3 to 4 times daily for 7 days
remove patch from the skin after at most 8-hour application
Children under 12 years of age:
consult a doctor.
* Please review the disclaimer below.
