FDA Label for Ultra Strength Pain Relief Balm
View Indications, Usage & Precautions
Ultra Strength Pain Relief Balm Product Label
The following document was submitted to the FDA by the labeler of this product Suzhou Vastech Medical Technology Co., Ltd. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredients Purpose
Camphor 11%........................................................ Topical analgesic
Menthol 11%.......................................................... Topical analgesic
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
* Please review the disclaimer below.