TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS- tetrahydrozoline hcl, zinc sulfate solution

Topcare Health Ultra Itch Relief Astringent Eye Drops by

Drug Labeling and Warnings

Topcare Health Ultra Itch Relief Astringent Eye Drops by is a Otc medication manufactured, distributed, or labeled by Topco Associates LLC, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Tetrahydrozoline HCl 0.05%

Zinc sulfate 0.25%

PURPOSE

Purposes

Tetrahydrozoline HCl...........Redness reliever

Zinc sulfate..........Astringent

INDICATIONS & USAGE

Use

• for temporary relief of discomfort and redness of the eye due to minor eye irritations

WARNINGS

Warnings

For external use only

Ask a doctor before use if you have narrow angle glaucoma

When using this product

• pupils may become enlarged temporarily
• to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
• if solution changes color or becomes cloudy, do not use
• overuse may produce increased redness of the eye
• remove contact lens before using

Stop use and ask a doctor if you experience

• eye pain
• changes in vision
• continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 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 (1-800-222-1222) right away.

DOSAGE & ADMINISTRATION

Directions

Instill 1 to 2 drops in the affected eye(s) up to 4 times daily

OTHER SAFETY INFORMATION

Other information

store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium chloride, sodium citrate

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE HEALTH ULTRA ITCH RELIEF ASTRINGENT EYE DROPS 
tetrahydrozoline hcl, zinc sulfate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-855
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g  in 100 mL
ZINC SULFATE (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37)	ZINC SULFATE	0.25 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BORIC ACID (UNII: R57ZHV85D4)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-855-01	1 in 1 CARTON	02/01/2020
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part349	02/01/2020

Labeler - Topco Associates LLC (006935977)

Registrant - K.C. Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(36800-855) , pack(36800-855) , label(36800-855)