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NDC 36800-0846-07 Top Care Ear Relief Ear Drops 10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL Details

Top Care Ear Relief Ear Drops 10; 15; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL

Top Care Ear Relief Ear Drops is a AURICULAR (OTIC) SOLUTION/ DROPS in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR.

Product Information

NDC	36800-0846
Product ID	36800-846_bb735629-b3d0-ff1f-e053-2995a90aae76
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	Top Care Ear Relief Ear Drops
Proprietary Name Suffix	n/a
Non-Proprietary Name	CHAMOMILE, 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	CHAMOMILE; MERCURIUS SOLUBILIS; SULFUR
Labeler Name	Topco Associates LLC
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 36800-0846-07 (36800084607)

Pricing Information	N/A
NDC Package Code	36800-846-07
Billing NDC	36800084607
Package	1 BOTTLE in 1 BOX (36800-846-07) / 12 mL in 1 BOTTLE
Marketing Start Date	2007-07-01
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 2e8422f3-546a-4d09-84c0-4aa809ceaa62 Details

Drug Facts

Active ingredients

Chamomilla 10X

Mercurius solubilis 15X

Sulphur 12X

Purpose

sensitivity to dreafts, soothing

fullness, sensitivity to cold

itchiness, sensitivity to water

The letters 'HPUS' indicate that the components in this product are officially monographed in the Homoeopathic Pharmacopoeia of the United States.

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 direted 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?

1-888-423-0139

Package Labeling:

INGREDIENTS AND APPEARANCE

TOP CARE EAR RELIEF EAR DROPS

chamomile, mercurius solubilis, sulfur solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:36800-846
Route of Administration	AURICULAR (OTIC)

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHAMOMILE (UNII: FGL3685T2X) (CHAMOMILE - UNII:FGL3685T2X)	CHAMOMILE	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:36800-846-07	1 in 1 BOX	07/01/2007
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		07/01/2007

Labeler - Topco Associates LLC (006935977)

Revised: 3/2021

Document Id: bb735629-b3d0-ff1f-e053-2995a90aae76

Set id: 2e8422f3-546a-4d09-84c0-4aa809ceaa62

Version: 1

Effective Time: 20210301