Hyland's Earache Drops

Drug Facts

Composition & Product

Active Ingredients

Chamomile (30 [hp_C]) Lycopodium Clavatum Spore Pulsatilla Patens Whole Sulfur Calcium Cation Belladonna Leaf

Inactive Ingredients

Glycerin Water Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status

UNAPPROVED HOMEOPATHIC Active Since 2023-07-27

Medication Information

Description

Active ingredients Purpose* Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) ear pain Calcarea Carbonica 30C HPUS ear pain, sensitivity to cold Chamomilla 30C HPUS ear pain, sensitivity to drafts, plugged ears Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching Sulphur 30C HPUS ear pain with burning, sensitivity to water HPUS" is the Homeopathic Pharmacopoeia of the United States.

Uses*

Temporarily relieves:

■ common pain or itching from swimmer’s ear

■ clogged ears

■ ear pain or itching from other earaches,

after diagnosis by a physician

Section 50565-1

Keep out of reach of children.

Section 50569-3

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.

Section 50570-1

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Section 53414-9

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1

Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician

Section 55106-9

Active ingredients	Purpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)	ear pain
Calcarea Carbonica 30C HPUS	ear pain, sensitivity to cold
Chamomilla 30C HPUS	ear pain, sensitivity to drafts, plugged ears
Lycopodium 30C HPUS	ear pain
Pulsatilla 30C HPUS	ear itching
Sulphur 30C HPUS	ear pain with burning, sensitivity to water

HPUS" is the Homeopathic Pharmacopoeia of the

United States.

Section 60561-8

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Warnings

Keep away from eyes.

Directions

Adults and children ages

4 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.

Questions?

www.hylands.com

or [email protected]

Inactive Ingredients

Citric Acid, Glycerine, Purified Water.

Principal Display Panel

Hyland's

Earache Drops 0.33 FL. OZ. (10 mL)

Structured Label Content

Uses*

Temporarily relieves:

■ common pain or itching from swimmer’s ear

■ clogged ears

■ ear pain or itching from other earaches,

after diagnosis by a physician

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

Do not use if you have ear tubes, damaged ear drums or after ear surgery.

Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use.

Section 55105-1 (55105-1)

Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician

Section 55106-9 (55106-9)

Active ingredients	Purpose*
Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated)	ear pain
Calcarea Carbonica 30C HPUS	ear pain, sensitivity to cold
Chamomilla 30C HPUS	ear pain, sensitivity to drafts, plugged ears
Lycopodium 30C HPUS	ear pain
Pulsatilla 30C HPUS	ear itching
Sulphur 30C HPUS	ear pain with burning, sensitivity to water

HPUS" is the Homeopathic Pharmacopoeia of the

United States.

Section 60561-8 (60561-8)

DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.

Warnings

Keep away from eyes.

Directions

Adults and children ages

4 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.

Questions?

www.hylands.com

or [email protected]

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerine, Purified Water.

Principal Display Panel

Hyland's

Earache Drops 0.33 FL. OZ. (10 mL)

Advanced Ingredient Data

[{"name": "CHAMOMILE", "unii": "FGL3685T2X", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "LYCOPODIUM CLAVATUM SPORE", "unii": "C88X29Y479", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "PULSATILLA PATENS WHOLE", "unii": "4M1169RWJD", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULFUR", "unii": "70FD1KFU70", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "CALCIUM CATION", "unii": "2M83C4R6ZB", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "BELLADONNA LEAF", "unii": "6GZW20TIOI", "classCode": "ACTIB", "strengthNumerator": "30", "strengthDenominator": "1", "strengthNumeratorUnit": "[hp_C]", "strengthDenominatorUnit": "mL"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses*": "Temporarily relieves: ■ common pain or itching from swimmer’s ear ■ clogged ears ■ ear pain or itching from other earaches, after diagnosis by a physician", "50565-1": "Keep out of reach of children.", "50569-3": "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.", "50570-1": "Do not use if you have ear tubes, damaged ear drums or after ear surgery.", "53414-9": "If pregnant or breastfeeding, ask a health professional before use.", "55105-1": "Temporarily relieves: common pain or itching from swimmer’s ear, clogged ears, ear pain or itching from other earaches, after diagnosis by a physician", "55106-9": "Active ingredients Purpose* Belladonna 30C HPUS (less than 0.000000000001% Alkaloids, calculated) ear pain Calcarea Carbonica 30C HPUS ear pain, sensitivity to cold Chamomilla 30C HPUS ear pain, sensitivity to drafts, plugged ears Lycopodium 30C HPUS ear pain Pulsatilla 30C HPUS ear itching Sulphur 30C HPUS ear pain with burning, sensitivity to water HPUS" is the Homeopathic Pharmacopoeia of the United States.", "60561-8": "DO NOT USE IF TAMPER-EVIDENT SEAL IS BROKEN OR MISSING.", "Warnings": "Keep away from eyes.", "Directions": "Adults and children ages 4 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.", "Questions?": "www.hylands.com or care@hylands.com", "Inactive ingredients": "Citric Acid, Glycerine, Purified Water.", "Principal Display Panel": "Hyland's Earache Drops 0.33 FL. OZ. (10 mL)"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information