Otc - Active Ingredient
Active ingredients Purpose
Camphor 11%........................................................ Topical analgesic
Menthol 11%.......................................................... Topical analgesic
Ultra Strength Pain Relief Balm
FDA Label NDC 71183-320
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 Ultra Strength Pain Relief Balm (NDC 71183-320). 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 - when using, otc - stop use, pregnancy, otc - keep out of reach of children, indications & usage, 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 of minor aches and pains of muscles and joints associated with over-exertion, simple backache, arhtritis, strains, and sprains.
Warnings
Warnings
For external use only.
Otc - When Using
When using this product
- Avoid contact with the eyes and mucous membranes
- Do not apply to open wounds or damaged skin
- Do not bandage or use heating pad
Otc - Stop Use
Stop use and ask a doctor if
- Condition worsens
- Severe skin irritation occurs
- Pain persists for more than seven days
- Pain clears up and then recurs a few days later
Pregnancy
If pregnant or breast feeding, ask a healthcare professional before use.
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.
Indications & Usage
Directions
- Rub well on the affected area. Repeat 3 to 4 times dailys.
- For children 2-12 years, consult a doctor before use.
Storage And Handling
Other information
This product may cause allergic reaction in some individuals. Test on small area before use.
Inactive Ingredient
Inactive ingredients
cajuput oil, clove oil, dementholized mint oil, paraffin petrolatuma
Dosage & Administration
Distributed by:
MCURE HEALTH SOLUTIONS INC.
20819 Currier Rd #200
City of Industry, CA 91789
Made in China
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