Otc - Active Ingredient
Active ingredients Purpose
Capsicum Extract Capsaicin 0.025%..............................Topical Analgesic
Hot Pain Relief
FDA Label NDC 71183-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Suzhou Vastech Medical Technology Co., Ltd for the product Hot Pain Relief (NDC 71183-002). 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, warnings, otc - do not use, otc - when using, otc - stop use, otc - pregnancy or breast feeding, 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
Uses
For temporary relief associated with:
- Arthritis
- Backaches
- Bruises
- Sprains & Strains
- Joint & Muscle Pain
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use:
- On the face or rashes
- With a heating pad
- On wounds or damaged skin
- if you are allergic to any ingredients of this product
Otc - When Using
When using this product:
- Use only as directed
- Avoid contact with the eyes, mucous membranes or rashes
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 - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
If swallowed, get medical help or contact a Poision Control Center right away.
Indications & Usage
Directions
Adults and Children 12 years of age and over:
Clean and dry affected area.
Peel off protective film and apply patch once or twice a day.
Apply patch an hour after and before shower or bath. Patch will remain effective for 8 hours.
Children Under 12 Years of Age: Consult a physician.
Inactive Ingredient
Inactive ingredients
Belladonna extract, camphor, diphenhydramine, lanolin, peppermint oil, rubber, vaseline, methyl salicylate, polyster resin, zinc oxide
Dosage & Administration
Distributed by:
MCURE HEALTH SOLUTIONS INC.
20819 Currier Rd #200
City of Industry, CA 91789
MADE IN CHINA
* Please review the disclaimer below.
