EAR/EYE/SINUS DROPS 5004- ear/eye/sinus drops liquid

Ear/Eye/Sinus Drops by

Drug Labeling and Warnings

Ear/Eye/Sinus Drops by is a Homeopathic medication manufactured, distributed, or labeled by Professional Complementary Health Formulas, Natural Pharmaceutical Manufacturing LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Vaccinium myrtillus 2X
Zingiber officinale 3X
Ear 6X, 12X, 30X, 60X, 100X
Eye 6X, 12X, 30X, 60X, 100X
Sinus 6X, 12X, 30X, 60X, 100X
Kali iodatum 6X
Graphites 12X

QUESTIONS

Professional Formulas

PO Box 2034 Lake Oswego, OR 97035

INDICATIONS

For the temporary relief of minor irritation of the eyes, ears, or sinuses due to a cold, hay fever, or other upper respiratory allergies.*

PURPOSE

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS

In case of overdose, get medical help or contact a poison control center right away.

Keep out of the reach of children.

If pregnant or breastfeeding, ask a healthcare professional before use.

DIRECTIONS

Place drops under tongue 30 minutes before/after meals. Adults and children 12 years and over: Take 10 drops up to 3 times per day. Consult a physician for use in children under 12 years of age.

OTHER INFORMATION

Tamper resistant. If seal is broken, do not use. After opening, close container tightly and store at room temperature away from heat.

INACTIVE INGREDIENTS

20% ethanol, purified water.

LABEL

Est 1985

Professional Formulas

Complementary Health

Ear/Eye/Sinus Drops

Homeopathic Remedy

2 FL. OZ. (59 mL)

INGREDIENTS AND APPEARANCE

EAR/EYE/SINUS DROPS  5004
ear/eye/sinus drops liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63083-5004
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BILBERRY (UNII: 9P2U39H18W) (BILBERRY - UNII:9P2U39H18W)	BILBERRY	2 [hp_X]  in 59 mL
GINGER (UNII: C5529G5JPQ) (GINGER - UNII:C5529G5JPQ)	GINGER	3 [hp_X]  in 59 mL
SUS SCROFA EAR (UNII: 7DX2J287CV) (SUS SCROFA EAR - UNII:7DX2J287CV)	SUS SCROFA EAR	6 [hp_X]  in 59 mL
BOS TAURUS EYE (UNII: VTW461N43P) (BOS TAURUS EYE - UNII:VTW461N43P)	BOS TAURUS EYE	6 [hp_X]  in 59 mL
SINUSITISINUM (UNII: B575563DM5) (SINUSITISINUM - UNII:B575563DM5)	SINUSITISINUM	6 [hp_X]  in 59 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	POTASSIUM IODIDE	6 [hp_X]  in 59 mL
GRAPHITE (UNII: 4QQN74LH4O) (GRAPHITE - UNII:4QQN74LH4O)	GRAPHITE	12 [hp_X]  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63083-5004-2	59 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	08/15/1985

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/15/1984

Labeler - Professional Complementary Health Formulas (167339027)

Registrant - Natural Pharmaceutical Manufacturing LLC (015624923)

Establishment
Name	Address	ID/FEI	Business Operations
Natural Pharmaceutical Manufacturing LLC		015624923	manufacture(63083-5004)