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NDC 68089-0004-01 Clear Sinus and Ear 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1 Details

Clear Sinus and Ear 3; 6; 3; 3 [hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1

Clear Sinus and Ear is a ORAL CAPSULE in the HUMAN OTC DRUG category. It is labeled and distributed by Clear Products, Inc.. The primary component is CALCIUM SULFATE; EUPHORBIA RESINIFERA RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS.

Product Information

NDC	68089-0004
Product ID	68089-004_97538efd-6ffa-95d1-e053-2995a90a17ff
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	Clear Sinus and Ear
Proprietary Name Suffix	n/a
Non-Proprietary Name	Pulsatilla Vulgaris, Euphorbia Resinifera Resin, Calcium Sulfate and Oyster Shell Calcium Carbonate, Crude
Product Type	HUMAN OTC DRUG
Dosage Form	CAPSULE
Route	ORAL
Active Ingredient Strength	3; 6; 3; 3
Active Ingredient Units	[hp_X]/1; [hp_X]/1; [hp_X]/1; [hp_X]/1
Substance Name	CALCIUM SULFATE; EUPHORBIA RESINIFERA RESIN; OYSTER SHELL CALCIUM CARBONATE, CRUDE; PULSATILLA VULGARIS
Labeler Name	Clear Products, Inc.
Pharmaceutical Class	Blood Coagulation Factor [EPC], Calcium [CS], Cations, Divalent [CS], Increased Coagulation Factor Activity [PE]
DEA Schedule	n/a
Marketing Category	UNAPPROVED HOMEOPATHIC
Application Number	n/a
Listing Certified Through	2024-12-31

Package

Package Images

NDC 68089-0004-01 (68089000401)

Pricing Information	N/A
NDC Package Code	68089-004-01
Billing NDC	68089000401
Package	60 CAPSULE in 1 BOTTLE (68089-004-01)
Marketing Start Date	2019-11-15
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL ddd711f5-bd4e-4e09-9749-3693aa167837 Details

SPL UNCLASSIFIED SECTION

DIRECTIONS:

Take 2 capsules three times per day as needed or as directed by your health care practitioner. Take with food. Do not exceed 12 capsules in a 24 hour period.

ACTIVE HOMEOPATHIC INGREDIENTS:

Pulsatilla 3X, Euphorium 6X, Hepar Sulphuricum 3X, Calcarea Carbonica 3X

OTHER INGREDIENTS:

(Herbal Extracts) Pueraria Root, Angelica Root, Peony Root, Magnolia Flower, Platycodon Root, Coix Seed, Ginger Root, Perilla Leaf, Siler Root, Scutellaria Root, Cinnamon Bark, Licorice Root, Vegi-Caps.

WARNING!

If symptoms do not improve or are accompanied by a fever, consult a doctor.

If you are pregnant, nursing,

taking medication, or have a medical condition, consult your physician before taking this product.

Do not take

if you are on anticoagulants or antiplatelet therapies, or heart medications.

Keep this and all other medications out of reach of children.

CLEAR SINUS AND EAR

is a unique homeopathic/herbal proprietary blend specifically formulated for the temporary relief of sinus and ear congestion related conditions.

CLEAR SINUS & EAR® is an exciting, all natural breakthrough for suffers of sinus & ear congestion, pain, pressure & tenderness, swimmer’s ear, cold & flu symptoms, and airborne allergies.

All Natural Relief for:

Hay Fever

Allergies

Cold/Flu Symptoms

Swimmer’s Ear

Principal Display Panel

Sinus Congestion Relief

The Original

CLEAR SINUS & EAR®

ALL NATURAL

GLUTEN AND LACTOSE FREE

VEGI-CAPS

Homeopathic / Herbal Formula

60 CAPSULES

INGREDIENTS AND APPEARANCE

CLEAR SINUS AND EAR

pulsatilla vulgaris, euphorbia resinifera resin, calcium sulfate and oyster shell calcium carbonate, crude capsule

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68089-004
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
PULSATILLA VULGARIS (UNII: I76KB35JEV) (PULSATILLA VULGARIS - UNII:I76KB35JEV)	PULSATILLA VULGARIS	3 [hp_X]
EUPHORBIA RESINIFERA RESIN (UNII: 1TI1O9028K) (EUPHORBIA RESINIFERA RESIN - UNII:1TI1O9028K)	EUPHORBIA RESINIFERA RESIN	6 [hp_X]
CALCIUM SULFATE (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM SULFATE	3 [hp_X]
OYSTER SHELL CALCIUM CARBONATE, CRUDE (UNII: 2E32821G6I) (OYSTER SHELL CALCIUM CARBONATE, CRUDE - UNII:2E32821G6I)	OYSTER SHELL CALCIUM CARBONATE, CRUDE	3 [hp_X]

Ingredient Name	Strength
Inactive Ingredients
PUERARIA MONTANA VAR. LOBATA ROOT (UNII: PET93F4I3C)
ANGELICA ATROPURPUREA ROOT (UNII: 885452N0GZ)
PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)
PLATYCODON GRANDIFLORUS ROOT (UNII: 2DF0NS0O2Z)
COIX LACRYMA-JOBI SEED (UNII: 4Q4V6NTZ1F)
GINGER (UNII: C5529G5JPQ)
PERILLA FRUTESCENS LEAF (UNII: T4L5881Y68)
SAPOSHNIKOVIA DIVARICATA ROOT (UNII: 8H84LFK2QD)
SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)
CINNAMON (UNII: 5S29HWU6QB)
LICORICE (UNII: 61ZBX54883)

Product Characteristics
Color	brown (light brown, tannish)	Score	no score
Shape	CAPSULE	Size	20mm
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68089-004-01	60 in 1 BOTTLE; Type 0: Not a Combination Product	11/15/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
unapproved homeopathic		08/01/2008

Labeler - Clear Products, Inc. (009605580)

Name	Address	ID/FEI	Business Operations
Establishment
HomeoCare Laboratories, Inc.		088248828	manufacture(68089-004)

Revised: 11/2019

Document Id: 97538efd-6ffa-95d1-e053-2995a90a17ff

Set id: ddd711f5-bd4e-4e09-9749-3693aa167837

Version: 3

Effective Time: 20191114