Equate Homeopathic Earache Drops

Equate Homeopathic Earache Drops
SPL v1
SPL
SPL Set ID ffbe8b3e-3694-e9be-e053-6394a90a9455
Route
AURICULAR (OTIC)
Published
Effective Date 2023-07-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2023-07-05

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 Pharmacopœia of the United States.


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 Pharmacopœia 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 42229-5

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Section 50565-1

Keep out of reach of children. If swallowed, contact a medical professional or Poison Control Center (1-800-222-1222) right away.

Section 50566-9

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 53413-1

1-888-287-1915

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 Pharmacopœia of the United States.

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.

Inactive Ingredients

Citric Acid, Glycerin, Purified Water.

Principal Display Panel

NDC 79903-198-01

equate™

Compare

to Hyland's

Earache

Drops active

ingredients

HOMEOPATHIC

Earache

Drops*

  • Relieves ear pain & clogging*
  • Swimmer's ear*
  • Cold & flu*
  • Allergy*

0.33 FL OZ (10mL)

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT

ACCEPTED MEDICAL EVIDENCE. NOT

FDA EVALUATED.


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 42229-5 (42229-5)

DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, contact a medical professional or Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

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 53413-1 (53413-1)

1-888-287-1915

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 Pharmacopœia of the United States.

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.

Inactive Ingredients (Inactive ingredients)

Citric Acid, Glycerin, Purified Water.

Principal Display Panel

NDC 79903-198-01

equate™

Compare

to Hyland's

Earache

Drops active

ingredients

HOMEOPATHIC

Earache

Drops*

  • Relieves ear pain & clogging*
  • Swimmer's ear*
  • Cold & flu*
  • Allergy*

0.33 FL OZ (10mL)

*CLAIMS BASED ON TRADITIONAL

HOMEOPATHIC PRACTICE, NOT

ACCEPTED MEDICAL EVIDENCE. NOT

FDA EVALUATED.


Advanced Ingredient Data


Raw Label Data

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