Hyland's Naturals Earache Drops

Hyland's Naturals Earache Drops
SPL v9
SPL
SPL Set ID 9b18453e-e338-4b8e-9856-85aca8c46ee1
Route
AURICULAR (OTIC)
Published
Effective Date 2015-03-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Belladonna Leaf (30 [hp_C]) Calcium Cation Chamomile Lycopodium Clavatum Spore Anemone Patens Whole Sulfur
Inactive Ingredients
Citric Acid Monohydrate Water Sodium Benzoate Glycerin

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2004-06-17 Until 2021-12-28

Description

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

Indications and Usage

Uses Temporarily relieves the symptoms of:  minor fever  ear pain or throbbing  irritability or occasional sleeplessness associated with earaches after diagnosis by a physician  common pain or itching of "swimmer’s ear" Temporarily relieves common pain or itching from swimmer’s ear, and other earache symptoms after diagnosis by a physician, including:  ear pain, throbbing or itching  irritability  occasional sleeplessness  minor fever

Purpose

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

Dosage and Administration

■ Shake well before using. Adults and children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Medication Information

Indications and Usage

Uses Temporarily relieves the symptoms of: 

  • minor fever 
  • ear pain or throbbing 
  • irritability or occasional sleeplessness associated with earaches after diagnosis by a physician 
  • common pain or itching of "swimmer’s ear"



Temporarily relieves common pain or itching from swimmer’s ear, and other earache symptoms after diagnosis by a physician, including:  ear pain, throbbing or itching  irritability  occasional sleeplessness  minor fever

Purpose

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

Dosage and Administration

■ Shake well before using. Adults and children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.

Description

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

Uses

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician,

including: ■ ear pain or itching ■ irritability ■ minor fever

Section 55106-9
Active ingredients Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor fever
Calcarea Carbonica 30C HPUS

throbbing ear pain
Chamomilla 30C HPUS

occasional sleeplessness and irritability
Lycopodium 30C HPUS ear pain
Pulsatilla 30C HPUS

ear itching, pain worse at night
Sulphur 30C HPUS ear pain with burning



"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Warnings

Keep away from eyes.

Directions

Adults and children ages 2 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

Do Not Use

you have ear tubes, damaged ear drums or after ear surgery.

Questions?

www.hylands.com or (800) 624-9659

Inactive Ingredients

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Principal Display Panel

Hyland's

NATURALS

Earache

Drops

RELIEVE EAR

PAIN FAST*

Swimmer's Ear

Cold & Flu

Allergy

AGES 2+

DAY & NIGHT

0.33 FL. OZ. (10 mL)

HOMEOPATHIC

If Pregnant Or Breastfeeding

ask a health professional before use.

Stop Use and Ask A Doctor If:

■ symptoms persist for more than 48 hours or worsen.

■ any discharge from ear is present.

■ symptoms are accompanied by a fever.

Dosage and Administration (dirctions)

■ Shake well before using. Adults and children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (tip

of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Structured Label Content

Uses

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician,

including: ■ ear pain or itching ■ irritability ■ minor fever

Section 55106-9 (55106-9)
Active ingredients Purpose

Belladonna 30C HPUS

(less than 0.000000000001% Alkaloids, calculated)

minor fever
Calcarea Carbonica 30C HPUS

throbbing ear pain
Chamomilla 30C HPUS

occasional sleeplessness and irritability
Lycopodium 30C HPUS ear pain
Pulsatilla 30C HPUS

ear itching, pain worse at night
Sulphur 30C HPUS ear pain with burning



"HPUS" indicates that the active ingredients are in the official Homeopathic Pharmacopœia of the United States.

Purpose

Temporarily relieves common pain or itching from swimmer’s ear, and symptoms of other earaches after diagnosis by a physician, including: ear pain or itching, irritability, minor fever

Warnings

Keep away from eyes.

Directions

Adults and children ages 2 years and over: ■ Tilt head sideways and apply 3-4 drops into involved ear (tip of applicator should not enter ear canal). ■ Keep head tilted for at least 2 minutes to keep drops in ear. ■ Repeat until relieved, up to 4 times per day. ■ Use as directed. ■ Do not refrigerate. ■ Shake well before using.

Do Not Use (Do not use)

you have ear tubes, damaged ear drums or after ear surgery.

Questions?

www.hylands.com or (800) 624-9659

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerine, Purified Water, Sodium Benzoate.

Indications and Usage

Uses Temporarily relieves the symptoms of: 

  • minor fever 
  • ear pain or throbbing 
  • irritability or occasional sleeplessness associated with earaches after diagnosis by a physician 
  • common pain or itching of "swimmer’s ear"



Temporarily relieves common pain or itching from swimmer’s ear, and other earache symptoms after diagnosis by a physician, including:  ear pain, throbbing or itching  irritability  occasional sleeplessness  minor fever

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Hyland's

NATURALS

Earache

Drops

RELIEVE EAR

PAIN FAST*

Swimmer's Ear

Cold & Flu

Allergy

AGES 2+

DAY & NIGHT

0.33 FL. OZ. (10 mL)

HOMEOPATHIC

If Pregnant Or Breastfeeding (If pregnant or breastfeeding)

ask a health professional before use.

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

■ symptoms persist for more than 48 hours or worsen.

■ any discharge from ear is present.

■ symptoms are accompanied by a fever.

Dosage and Administration (dirctions) (Dosage and Administration (Dirctions))

■ Shake well before using. Adults and children ages 2 years and over: Tilt head sideways and apply 3-4 drops into involved ear (tip

of applicator should not enter ear canal). Keep head tilted for at least 2 minutes to keep drops in ear. Repeat until relieved, up to 4 times daily.


Advanced Ingredient Data


Raw Label Data

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