Ring Relief ® Pm Nighttime Formula Ear Drops

Ring Relief ® Pm Nighttime Formula Ear Drops
SPL v5
SPL
SPL Set ID 92ef0dd1-84f9-086c-e053-2a95a90ac647
Route
AURICULAR (OTIC)
Published
Effective Date 2024-03-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X]) Calcium Sulfide (13 [hp_X]) Hypericum Perforatum (12 [hp_X]) Lycopodium Clavatum Spore (5 [hp_X]) Matricaria Chamomilla Salicylic Acid Silicon Dioxide Valerian Allylthiourea Passiflora Incarnata Flower
Inactive Ingredients
Glycerin Benzalkonium Chloride Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-19

Description

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.


Medication Information

Warnings and Precautions

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.

Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Indications and 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.

Dosage and 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.

Description

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.

Section 42229-5

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.

Section 50570-1

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.

Section 51727-6

Inactive Ingredients:



Benzalkonium Chloride, Glycerin, Purified Water.

Section 51945-4

FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

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

Section 55106-9

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.

Stop Use

Stop use and ask a doctor if: • You experience ear pain or worsening symptoms. • Your symptoms last longer than 7 days

Questions Or Comments?

www.thereliefproducts.com, 1-888-969-6855

Keep Out of Reach of Children

• Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Do not get into eyes. If contact occurs, rinse eyes thoroughly with water.

Section 42229-5 (42229-5)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredients:



Benzalkonium Chloride, Glycerin, Purified Water.

Section 51945-4 (51945-4)

FDA Disclaimer: Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

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.

Stop Use

Stop use and ask a doctor if: • You experience ear pain or worsening symptoms. • Your symptoms last longer than 7 days

Questions Or Comments? (Questions or comments?)

www.thereliefproducts.com, 1-888-969-6855

Keep Out of Reach of Children (Keep out of reach of children)

• Keep out of reach of children.

In case of accidental ingestion, get medical help or contact a Poison Control Center right away.


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