Swimmer’s Ear Complete Relief ™

Swimmer’s Ear Complete Relief ™
SPL v3
SPL
SPL Set ID a3425da3-ace9-05c2-e053-2995a90ab09f
Route
AURICULAR (OTIC)
Published
Effective Date 2020-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Potassium Cation (12 [hp_X]) Calcium Sulfide (13 [hp_X]) Phosphate Ion (6 [hp_X]) Silicon Dioxide Valerian Loeselia Mexicana Top Mercurius Solubilis
Inactive Ingredients
Alcohol Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2020-04-11

Description

Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort Kali muriaticum HPUS 12X, 18X ........................Clogged ear Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming "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.

Flammable: Keep away from fire or flame.

Indications and Usage

Uses:*

According to homeopathic indications these ingredients provide temporary relief from symptoms such as: • Sensitivity to touch in ear • Pain and discomfort • Water/Congestion in ear • Swimmer’s ear irritation; 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. • Apply 4-5 drops in each affected ear. • 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

Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort Kali muriaticum HPUS 12X, 18X ........................Clogged ear Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming "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 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. • Swimmer’s Ear Complete Relief TM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

Section 50570-1

Do not use: in the eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6

Inactive Ingredients:

Glycerin, Isopropyl alcohol 94%

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

Calcarea phosphorica HPUS - Itching, irritability

Hepar sulphuris calcareum HPUS - Sensitive to touch, water

Hoitzia HPUS - Fullness in the ear, water, pain and discomfort

Kali muriaticum HPUS - Clogged ear

Mercurius solubilis HPUS - Swimmer's ear irritation

Valeriana officinalis HPUS - Relaxing, calming

Section 55106-9

Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability

Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water

Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort

Kali muriaticum HPUS 12X, 18X ........................Clogged ear

Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation

Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming

"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, irritation (too much burning) or worsening symptoms. • Your symptoms last longer than 7 days

Ask Doctor

Ask a doctor before use if you have: • Ear Drainage or discharge • pain, irritation, or a rash in the ear • dizziness • had ear surgery

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: • Sensitivity to touch in ear • Pain and discomfort • Water/Congestion in ear • Swimmer’s ear irritation; 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. • Apply 4-5 drops in each affected ear. • 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.

Flammable: Keep away from fire or flame.

Section 42229-5 (42229-5)

Other information:

• Non-prescription drug products cannot treat infections. • 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. • Swimmer’s Ear Complete Relief TM Ear Drops are homeopathic dilutions, for details see www.thereliefproducts.com.

Section 50570-1 (50570-1)

Do not use: in the eyes. If contact occurs, rinse eyes thoroughly with water

Section 51727-6 (51727-6)

Inactive Ingredients:

Glycerin, Isopropyl alcohol 94%

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)

Calcarea phosphorica HPUS - Itching, irritability

Hepar sulphuris calcareum HPUS - Sensitive to touch, water

Hoitzia HPUS - Fullness in the ear, water, pain and discomfort

Kali muriaticum HPUS - Clogged ear

Mercurius solubilis HPUS - Swimmer's ear irritation

Valeriana officinalis HPUS - Relaxing, calming

Section 55106-9 (55106-9)

Calcarea phosphorica HPUS 12X, 18X...............Itching, irritability

Hepar sulphuris calcareum HPUS 12X, 18X.......Sensitive to touch, water

Hoitzia HPUS 12X, 18X.......................................Fullness in the ear, water, pain and discomfort

Kali muriaticum HPUS 12X, 18X ........................Clogged ear

Mercurius solubilis HPUS 12X, 18X....................Swimmer's ear irritation

Valeriana officinalis HPUS 12X, 18X...................Relaxing, calming

"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, irritation (too much burning) or worsening symptoms. • Your symptoms last longer than 7 days

Ask Doctor (Ask doctor)

Ask a doctor before use if you have: • Ear Drainage or discharge • pain, irritation, or a rash in the ear • dizziness • had ear surgery

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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