Mullein Ear Drops

Mullein Ear Drops
SPL v2
SPL
SPL Set ID 299331bd-9318-6d80-e063-6294a90ab889
Route
AURICULAR (OTIC)
Published
Effective Date 2024-12-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Verbascum Thapsus (30 [hp_C]) Atropa Belladonna Calendula Officinalis Flowering Top Viola Odorata Whole Echinacea, Unspecified Goldenseal
Inactive Ingredients
Alcohol

Identifiers & Packaging

Pill Appearance
Size: 15 mm Score: 1
Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2015-01-01

Description

How to Use Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)


Medication Information

Warnings and Precautions

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Indications and Usage

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage and Administration

How to Use

Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)

Description

How to Use Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)

Section 50565-1

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

Section 51727-6

Inactive: Alcohol Base to Preserve Remedy

Section 51945-4

Entire package label

Section 55105-1

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 55106-9

Belladonna D10: 0.008mL (HPUS)

Calendula Ø: 0.010mL (HPUS)

Echinacea Ø: 0.002mL (HPUS)

Hydrastis D3: 0.002mL (HPUS)

Mullein Oil Ø: 0.28mL (HPUS)

Viola Odorata Ø: 0.002mL (HPUS)


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Dosage and Administration (34068-7)

How to Use

Apply 4-5 drops into the ear twice daily or as directed by a healthcare provider. (For external use only.)

Warnings and Precautions (34071-1)

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 50565-1 (50565-1)

Warnings and Storage:

Ask a professional before use if pregnant or breastfeeding or if you have severe symptoms.

Keep away from children. If you have a reaction to this product that is not positive, discontinue use. Store in a cool and dry place.

Section 51727-6 (51727-6)

Inactive: Alcohol Base to Preserve Remedy

Section 51945-4 (51945-4)

Entire package label

Section 55105-1 (55105-1)

Uses

Temporarily supports softer earwax and ear cleanliness.*

*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE, NOT ACCEPTED MEDICAL EVIDENCE, NOT FDA EVALUATED.

This product is not intended to diagnose, treat, cure, or prevent any disease.

Section 55106-9 (55106-9)

Belladonna D10: 0.008mL (HPUS)

Calendula Ø: 0.010mL (HPUS)

Echinacea Ø: 0.002mL (HPUS)

Hydrastis D3: 0.002mL (HPUS)

Mullein Oil Ø: 0.28mL (HPUS)

Viola Odorata Ø: 0.002mL (HPUS)


Advanced Ingredient Data


Raw Label Data

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