FAMILY WELLNESS EAR RELIEF EAR DROPS- matricaria chamomilla, mercurius solubilis, sulfur solution/ drops

Family Wellness Ear Relief Ear Drops by

Drug Labeling and Warnings

Family Wellness Ear Relief Ear Drops by is a Homeopathic medication manufactured, distributed, or labeled by Family Dollar Services Inc, Bell Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Chamomilla 10X

Mecurius Soluctions 15X

Sulphur 12X

Purpose

sensitivity to drafts, soothingfullness, sensitivity to cold itchiness, sensitvity to water

Uses

Helps relieve the sensation of fullnes of the ear, sensitivity to water and drafts, and the annoyance of water-clogged ears by helping clear water trapped in the ear.

Warnings

• Do not use in the eyes.
• Intial exacerbation may occur.

Ask a doctor before use if you have:

• ear drainage or discharge
• pain, irritation, or rash in the ear
• had ear surgery
• dizziness

Stop use and ask a doctor if:

• irritation (too much burning) or pain occurs
• symptoms persist for more than 48 hours

If pregnant or breast feeding,

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

FOR USE IN THE EAR ONLY.

• Remove tamper-evident seal from neck of bottle.
• Twist cap off bottle.
• Tilt head sideways.
• Apply 4 to 5 drops in each affected ear (applicator should not enter ear canal).
• Keep drops in ear by keeping head tilted or placing cotton in ear.
• Use up to 4 times daily for no more than 48 hours, or as directed by a doctor.
• Children under 12 years of age consult a doctor.

Other information

Active ingredients are manufactured according to homeopathic principles
Do not use if tamper-evident safety seal is missing or broken

Inactive ingredients

Vegetable glycerin

Questions?

1-800-328-5890

Package Labeling:

INGREDIENTS AND APPEARANCE

FAMILY WELLNESS EAR RELIEF EAR DROPS 
matricaria chamomilla, mercurius solubilis, sulfur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55319-804
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA	10 [hp_X]  in 1 mL
MERCURIUS SOLUBILIS (UNII: 324Y4038G2) (MERCURIUS SOLUBILIS - UNII:324Y4038G2)	MERCURIUS SOLUBILIS	15 [hp_X]  in 1 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70)	SULFUR	12 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55319-804-01	1 in 1 CARTON	11/01/2019
1		12 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		11/01/2019

Labeler - Family Dollar Services Inc (024472631)

Establishment
Name	Address	ID/FEI	Business Operations
Bell Pharmaceuticals, Inc.		140653770	manufacture(55319-804)