Earache Relief ® Pm Nighttime Formula

Earache Relief ® Pm Nighttime Formula
SPL v5
SPL
SPL Set ID 92ee4f15-7315-7a46-e053-2995a90a7d0a
Route
AURICULAR (OTIC)
Published
Effective Date 2023-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Valerian (6 [hp_X]) Arnica Montana (3 [hp_X]) Echinacea Angustifolia (12 [hp_X]) Matricaria Chamomilla (5 [hp_X]) Apis Mellifera (8 [hp_X]) Loeselia Mexicana Whole Passiflora Incarnata Flower Phosphate Ion Calcium Sulfide
Inactive Ingredients
Benzalkonium Chloride Glycerin Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-09-19

Description

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness Echinacea HPUS 3x...............................................Immune support Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness Passiflora HPUS 5x ................................................Sleep disorders, exhaustion Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid "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.
Indications and Usage

Uses:*

• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Discomfort • Itching, coldness, irritability • Sensitivity to water, wind and touch • Fullness, congestion • 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.



*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.

Description

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness Echinacea HPUS 3x...............................................Immune support Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness Passiflora HPUS 5x ................................................Sleep disorders, exhaustion Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid "HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Section 42229-5

Other information:

• Non-prescription drug products cannot treat infections. • Store at room temperature 15o to 30o C (59o to 86o 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. • EarAche Relief ® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

Section 50566-9

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

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

Apis mellifica HPUS - Discomfort, redness of external ear

Arnica montana HPUS - Bruised aching pain

Calcarea phosphorica HPUS - Itching, irritability

Chamomilla HPUS - Pain disturbs sleep, restlessness

Echinacea HPUS - Immune support

Hepar sulphuris calcareum - Sensitive to touch, water, wind, cold

Hoitzia HPUS - Fever, fullness

Passiflora HPUS - Sleep disorders, exhaustion

Valeriana officinalis HPUS - Relaxing, calming sleep aid

Section 55106-9

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear

Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain

Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability

Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness

Echinacea HPUS 3x...............................................Immune support

Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold

Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness

Passiflora HPUS 5x ................................................Sleep disorders, exhaustion

Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid

"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

Questions Or Comments?

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

Keep Out of Reach of Children

Keep out of reach of children


Structured Label Content

Indications and Usage (34067-9)

Uses:*

• According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Discomfort • Itching, coldness, irritability • Sensitivity to water, wind and touch • Fullness, congestion • 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.



*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.

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.
Section 42229-5 (42229-5)

Other information:

• Non-prescription drug products cannot treat infections. • Store at room temperature 15o to 30o C (59o to 86o 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. • EarAche Relief ® PM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

Section 50566-9 (50566-9)

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

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)

Apis mellifica HPUS - Discomfort, redness of external ear

Arnica montana HPUS - Bruised aching pain

Calcarea phosphorica HPUS - Itching, irritability

Chamomilla HPUS - Pain disturbs sleep, restlessness

Echinacea HPUS - Immune support

Hepar sulphuris calcareum - Sensitive to touch, water, wind, cold

Hoitzia HPUS - Fever, fullness

Passiflora HPUS - Sleep disorders, exhaustion

Valeriana officinalis HPUS - Relaxing, calming sleep aid

Section 55106-9 (55106-9)

Apis mellifica HPUS 6x, 12x, 18x...........................Discomfort, redness of external ear

Arnica montana HPUS 6x, 12x, 18x.......................Bruised aching pain

Calcarea phosphorica HPUS 8x, 12x, 18x.............Itching, irritability

Chamomilla HPUS 12x,18x....................................Pain disturbs sleep, restlessness

Echinacea HPUS 3x...............................................Immune support

Hepar sulphuris calcareum HPUS 8x, 12x, 18x......Sensitive to touch, water, wind, cold

Hoitzia HPUS 6x, 12x, 18x......................................Fever, fullness

Passiflora HPUS 5x ................................................Sleep disorders, exhaustion

Valeriana officinalis HPUS 6x..................................Relaxing, calming sleep aid

"HPUS" indicates the active ingredients are in the Homeopathic Pharmacopoeia of the United States.

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


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