FDA Label for Cooling Acute Pain Relief
View Indications, Usage & Precautions
Cooling Acute Pain Relief Product Label
The following document was submitted to the FDA by the labeler of this product King Bio 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.
Otc - Active Ingredient
Drug Facts__________________________________________________________________________________________________________
HPUS active ingredients
Aesculus hippocastanum, Arnica montana, Bellis perennis, Bryonia, Calcarea carbonica, Calcarea fluorica, Cimicifuga racemosa, Cobaltum metallicum, Gnaphalium polycephalum, Hypericum perforatum, Kali carbonicum, Kali phosphoricum, Magnesia phosphorica, Oxalicum acidum, Phosphorus, Rhus toxicodendron, Ruta graveolens, Zincum metallicum.
Equal volumes of each active ingredient in 10X, 30X, and LM1 potencies. Active ingredients 50% of total weight.
Indications & Usage
Uses for temporary relief of symptoms: •back and neck pain •muscle and joint pain •muscle cramps and stiffness •inflamed muscles and joints •muscle tension and soreness •body aches •tired legs and feet •stiff and swollen joints
Warnings
Warnings
- For external use only. Avoid contact with eyes and broken skin.
- Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
- Nursing mothers should not apply to breast area.
- Keep out of reach of children.
- If swallowed, get medical help or contact a Poison Control Center immediately.
Otc - Keep Out Of Reach Of Children
- Keep out of reach of children.
Dosage & Administration
Directions
•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.
Other Safety Information
Other information:
- To open: unscrew cap, remove tube seal, replace cap.
- Safety sealed for your protection.
- Do not use if tube seal is missing.
- Store at 68-77° (20-25°C).
Inactive Ingredient
Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, menthol, peppermint oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lacyltate, sweet almond oil, sweet birch oil.
Otc - Purpose
Uses: for temporary relief of symptoms:
- back and neck pain
- muscle and joint pain
- muscle cramps and stiffness
- inflamed muscles and joints
- muscle tension and soreness
- body aches
- tired legs and feet
- stiff and swollen joints
* Please review the disclaimer below.
