RING RELIEF PM NIGHTTIME FORMULA- arnica montana, calcium sulfide, hypericum perforatum, lycopodium clavatum spore, thiosinaminum, mercurius solubilis, salicylic acid, silicon dioxide, allylthiourea liquid

Ring Relief PM Nighttime Formula by

Drug Labeling and Warnings

Ring Relief PM Nighttime Formula by is a Homeopathic medication manufactured, distributed, or labeled by TRP Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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.

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

PREGNANCY OR BREAST FEEDING

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

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.

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

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.

SPL UNCLASSIFIED SECTION

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

Stop Use

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

PRINCIPAL DISPLAY PANEL

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

INGREDIENTS AND APPEARANCE

RING RELIEF PM NIGHTTIME FORMULA 
arnica montana, calcium sulfide, hypericum perforatum, lycopodium clavatum spore, thiosinaminum, mercurius solubilis, salicylic acid, silicon dioxide, allylthiourea liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 17312-175
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW)	ARNICA MONTANA	6 [hp_X]  in 1 mL
CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q)	CALCIUM SULFIDE	13 [hp_X]  in 1 mL
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	6 [hp_X]  in 1 mL
LYCOPODIUM CLAVATUM SPORE (UNII: C88X29Y479) (LYCOPODIUM CLAVATUM SPORE - UNII:C88X29Y479)	LYCOPODIUM CLAVATUM SPORE	12 [hp_X]  in 1 mL
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	12 [hp_X]  in 1 mL
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	6 [hp_X]  in 1 mL
SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4)	SILICON DIOXIDE	13 [hp_X]  in 1 mL
VALERIAN (UNII: JWF5YAW3QW) (VALERIAN - UNII:JWF5YAW3QW)	VALERIAN	6 [hp_X]  in 1 mL
ALLYLTHIOUREA (UNII: 706IDJ14B7) (ALLYLTHIOUREA - UNII:706IDJ14B7)	ALLYLTHIOUREA	6 [hp_X]  in 1 mL
PASSIFLORA INCARNATA FLOWER (UNII: K8F3G29S6Z) (PASSIFLORA INCARNATA FLOWER - UNII:K8F3G29S6Z)	PASSIFLORA INCARNATA FLOWER	5 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17312-175-15	1 in 1 PACKAGE	09/19/2019
1		10 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		09/19/2019

Labeler - TRP Company (105185719)

Registrant - TRP Company (105185719)