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NDC 63868-0604-01 Quality Choice Ear Relief Drops 10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Quality Choice Ear Relief Drops 10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Quality Choice Ear Relief Drops is a AURICULAR (OTIC) SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Chain Drug Marketing Association. The primary component is MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; SULFUR.

Product Information

NDC	63868-0604
Product ID	63868-604_a0a6acdd-6aac-613b-e053-2995a90aa86f
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Quality Choice Ear Relief Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	MATRICARIA CHAMOMILLA WHOLE, MERCURIUS SOLUBILIS, SULFUR
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION/ DROPS
Route	AURICULAR (OTIC)
Active Ingredient Strength	10; 15; 12
Active Ingredient Units	[hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Substance Name	MATRICARIA CHAMOMILLA WHOLE; MERCURIUS SOLUBILIS; SULFUR
Labeler Name	Chain Drug Marketing Association
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 63868-0604-01 (63868060401)

Pricing Information	N/A
NDC Package Code	63868-604-01
Billing NDC	63868060401
Package	1 BOTTLE in 1 BOX (63868-604-01) / 12 mL in 1 BOTTLE
Marketing Start Date	2013-10-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 8a4b75d2-cec0-4ac3-94e3-208a01feace7 Details

Drug Facts

Active ingredients

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

sensitivity to drafts, soothing fullness, sensitivity to cold itchingness, sensitivity to water

Uses

Helps relieve the sensation of fullness 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.
Initial 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 ingredient

Vegetable glycerin

Questions?

248-449-9300

Package Labeling:

INGREDIENTS AND APPEARANCE

QUALITY CHOICE EAR RELIEF DROPS

matricaria chamomilla whole, mercurius solubilis, sulfur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63868-604
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MATRICARIA CHAMOMILLA WHOLE (UNII: G0R4UBI2ZZ) (MATRICARIA CHAMOMILLA - UNII:G0R4UBI2ZZ)	MATRICARIA CHAMOMILLA WHOLE	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

Ingredient Name	Strength
Inactive Ingredients
GLYCERIN (UNII: PDC6A3C0OX)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:63868-604-01	1 in 1 BOX	10/01/2013
1		12 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		10/01/2013

Labeler - Chain Drug Marketing Association (011920774)

Name	Address	ID/FEI	Business Operations
Establishment
Bell Pharmaceuticals, Inc.		140653770	manufacture(63868-604)

Revised: 3/2020

Document Id: a0a6acdd-6aac-613b-e053-2995a90aa86f

Set id: 8a4b75d2-cec0-4ac3-94e3-208a01feace7

Version: 1

Effective Time: 20200312