FDA Label for Pain Relieving
View Indications, Usage & Precautions
Pain Relieving Product Label
The following document was submitted to the FDA by the labeler of this product Safetec Of America, Inc.. 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.
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Drug Facts
Active Ingredient
Menthol USP 4%
Purpose
Cooling Pain Relief
Use
Temporary relief from minor aches and pains of sore muscles and joints associated with: arthritis, backache, strains sprains.
Warnings
- For external use only.
Flammable: Keep away from excessive heat or open flame.
Otc - Ask Doctor
Ask a doctor before use if you have: sensitive skin.
When Using This Product:
- Avoid contact with eyes or mucous membranes
- Do not apply to wounds or damaged skin
- Do not use with other ointments, creams, sprays or liniments
- Do not apply to irritated skin or if excessive irritation develops
- Do not bandage
- Wash hands after use with cool water
- Do not use with heating pad or device
Stop Use And Ask A Doctor If:
- Condition worsens
- Symptoms last more than 7 days or 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, contact a physician or Poison Control Center right away
Directions
- Adults and children 2 years of age and older: Rub a thin film over affected areas not more than 4 times daily; massage not necessary
- Children under 2 years of age: Consult a physician
Other Information
Store in a cool dry place.
Inactive Ingredients
Aloe Barbadensis Leaf Extract, Arctium Lappa Root Extract, Arnica Montana Flower Extract, Boswellia Carterii Resin Extract, Brilliant Blue, Calendula Officinalis Extract, Camellia Sinensis Leaf Extract (Green Tea Leal), Camphor, Carbomer, Glycerin, Ilex Paraguariensis Leaf Extract, Isopropyl Alcohol, Isopropyl Myristate, Melissa Officinalis Leaf Extract, Purified Water, Silicon Dioxide, Tartrazine, TocopheryI Acetate, Triethanolamine.
Package Label.Principal Display Panel
Principal Display Panel – 4 oz Pain Relieving Gel
Safetec®
Pain Relieving Gel
For Minor Aches & Pains of Muscles & Joints
Net Wt. 4 oz. (113.4g)
Reorder No. 58002
Manufactured for: Safetec of America, Inc.
Buffalo, NY 14215 I 1-800-456-7077
Made in India KD/739
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