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FDA Approval

Bestmade Natural Products - Mullein Ear Drops

Bestmade Natural Products (DUNS: 047124582)

May 27, 2025

HUMAN OTC DRUG LABEL

verbascum thapsus(30 [hp_C] in 30 [hp_C])
Belladonna(30 [hp_C] in 30 [hp_C])
viola odorata whole(30 [hp_C] in 30 [hp_C])
Echinacea(30 [hp_C] in 30 [hp_C])
Goldenseal(30 [hp_C] in 30 [hp_C])
Calendula officinalis flower(30 [hp_C] in 30 [hp_C])

Manufacturing Establishments (1)

Total Operations Management LLC DBA: Bestmade Natural Products Micro

Bestmade Natural Products

047124582

Products (1)

Bestmade Natural Products - Mullein Ear Drops

82969-6015

AURICULAR (OTIC)

May 27, 2025

ALCOHOLInactive
Code: 3K9958V90MClass: IACTQuantity: 30 [hp_C] in 30 [hp_C]
verbascum thapsusActive
Code: C9TD27U172Class: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
Code: WQZ3G9PF0HClass: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
viola odorata wholeActive
Code: AET12U8B74Class: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
EchinaceaActive
Code: 4N9P6CC1DXClass: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
Code: ZW3Z11D0JVClass: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]
Code: 18E7415PXQClass: ACTIBQuantity: 30 [hp_C] in 30 [hp_C]

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Entire package label

mullein


INDICATIONS & USAGE SECTION

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 & ADMINISTRATION SECTION

How to Use

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


WARNINGS SECTION

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.


OTC - ACTIVE INGREDIENT SECTION

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)

OTC - PURPOSE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.


INACTIVE INGREDIENT SECTION

Inactive: Alcohol Base to Preserve Remedy


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