FDA Label for Soothanol X2
View Indications, Usage & Precautions
Soothanol X2 Product Label
The following document was submitted to the FDA by the labeler of this product Newmarket Health Products Llc. 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
Capsaicin 0.20%
Menthol 12%
Otc - Purpose
Purpose
Topical Analgesic
Topical Analgesic
Indications & Usage
Uses for temporary relief of minor aches and pains of muscles and joints associated with:
- simple backache
- arthritis
- strains
- bruises
- sprains
Warnings
Warnings
For external use only.
Otc - When Using
When using this product
- avoid contact with eyes or mucus membranes
- do not bandage tighly
- do not apply to wounds or damaged skin
Otc - Stop Use
Stop use and ask doctor if
- condition worsens
- symptoms persist for more than 7 days or clear up and occur again within a few days
- excessive irritation of skin develops
Pregnancy
If pregnant or breast feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
If swallowed get medical help or contact a Poison Control Center right away.
Other information
Store in a cool, dry place.
Dosage & Administration
Directions
- adults and children 12 years of age and older: wash hands and affected area with lukewarm water and apply 2-3 drops with fingertips not more than 3 to 4 times daily
- children under 12 years of age: consult a physician
- do not use otherwise than as directed
Inactive Ingredient
Inactive ingredients
arnica flower, calendula flower, dimethyl sulfoxide (DMSO), d-Limonene oil, emu oil (non-vegetarian), extra virgin olive oil, ginger root, methylsulfonylmethane (MSM), st. john's wort, wintergreen oil
Otc - Questions
Questions or comments?
Call (800) 895-2108, Monday through Friday, 8am-8pm EST
Package Label.Principal Display Panel
North Star
Nutritionals
SOOTHANOL X2
Pain Relieving Drops
Net: 1 Fluid OZ/ 30 ML
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