FDA Label for Ring Relief Pm Nighttime Formula
View Indications, Usage & Precautions
Ring Relief Pm Nighttime Formula Product Label
The following document was submitted to the FDA by the labeler of this product Trp Company. 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
Arnica montana HPUS 6X, 30X................Buzzing, chirping
Chamomilla HPUS 12X, 18X....................Pain, disturbed sleep
Hepar sulphuris calcareum HPUS 13X....Noise sensitivity
Hypericum perforatum HPUS 6X, 30X.....Nerve sensitivity
Lycopodium clavatum HPUS 12X............Pounding, ear wax buildup
Passiflora HPUS 5X.................................Relaxing, calming sleep aid
Salicylicum acidum HPUS 6X..................Ringing, buzzing
Silicea HPUS 13X....................................Roaring
Thiosinaminum HPUS 6X........................Ringing (Tinnitus)
Valeriana officinalis HPUS 6X..................Sleeplessness
"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.
Otc - Purpose
Arnica montana HPUS- Buzzing, chirping
Chamomilla HPUS - Pain, disturbed sleep
Hepar sulphuris calcareum HPUS - Noise sensitivity
Hypericum perforatum HPUS - Nerve sensitivity
Lycopodium clavatum HPUS - Pounding, ear wax buildup
Passiflora HPUS - Relaxing, calming sleep aid
Salicylicum acidum HPUS - Ringing, buzzing
Silicea HPUS - Roaring
Thiosinaminum HPUS - Ringing (Tinnitus)
Valeriana officinalis HPUS - Sleeplessness
Indications & Usage
Uses:*
According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Ringing, buzzing, roaring • Nerve and noise sensitivity • Pounding • Discomfort • Wax buildup • Sleeplessness; after serious causes have been ruled out by a physician.
*These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.
Warnings
Warnings:
A PHYSICIAN SHOULD ALWAYS BE CONSULTED TO RULE OUT SERIOUS CAUSES. For External Use Only.
- This product is intended to complement, not replace, standard medical treatment.
- Initial worsening of symptoms may occur.
- In case of accidental ingestion, get medical help or contact a Poison Control Center right away.
- Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Do Not Use
Do not use:
- If solution changes color or becomes cloudy.
- If you have ear drainage, discharge, irritation, a rash in the ear or dizziness.
- If you have ear tubes, after surgery or with damaged ear drums.
Keep Out Of Reach Of Children
• Keep out of reach of children.
Dosage & Administration
Directions:
• Suitable for adults and children ages 2 and over. Children under the age of 2: Consult a physician before use. • For use in ear only. • Use 3 to 5 drops before bedtime. • Warm contents to body temperature by holding bottle in your hands. • Tilt your head to the side and let solution drip into the ear. • Never put the tip into the ear canal. • Keep drops in your ear by tilting your head for 20 to 40 seconds. • Homeopathic remedies may not be effective for everyone. Individual results may vary. May take up to 60 days to see results.
Other
Other information:
• Store at room temperature 15° to 30° C (59° to 86°F). • Keep bottle tightly closed. • Active ingredients are micro-diluted in accordance with the Homeopathic Pharmacopoeia of the United States and are therefore non-toxic with no known side effects or contraindications. • Ring Relief® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.
Inactive Ingredient
Inactive Ingredients:
Benzalkonium Chloride, Glycerin, Purified Water.
Questions Or Comments?
www.thereliefproducts.com, 1-888-969-6855
Package Label.Principal Display Panel
FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.
* Please review the disclaimer below.