TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS- glycerin, naphazoline hydrochloride solution

Topcare Maximum Redness Relief Eye Drops by

Drug Labeling and Warnings

Topcare Maximum Redness Relief Eye Drops by is a Otc medication manufactured, distributed, or labeled by Topco Assoc LLC, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Glycerin.....0.5%

Naphazoline hydrochloride....0.03%

PURPOSE

Purpose

Glycerin..................................Lubricant

Naphazoline hydrochloride.....Redness reliever

INDICATIONS & USAGE

Uses

• For the relief of redness of the eye due to minor eye irritations
• For the temporary relief of burning and irritation due to dryness of the eye
• For use as a protectant against further irritation or dryness of the eye

WARNINGS

Warnings

For external use only

Do not use if solution changes color or becomes cloudy

Ask a doctor before use if you have narrow angle glaucoma

When using this product

• To avoid contamination, do not touch tip of container to any surface
• Replace cap after using
• Overuse may produce increased redness of the eye
• Pupils may become enlarged temporarily

Stop use and ask a doctor if

• you experience eye pain
• you experience changes in vision
• you experience continued redness or irritation of the eye
• the condition worsens or persists for more than 72 hours

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

Inatill 1 or 2 drops in the affected eye(s) up to 4 times daily.

OTHER SAFETY INFORMATION

Other information

• store at room temperature
• remove contact lenses before using
• Tamper evident: Do not use this product if imprinted neckband is missing or broken

INACTIVE INGREDIENT

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

TOPCARE MAXIMUM REDNESS RELIEF EYE DROPS 
glycerin, naphazoline hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 36800-975
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.5 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.03 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 36800-975-01	1 in 1 CARTON	02/04/2020
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	02/04/2020

Labeler - Topco Assoc LLC (006935977)

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

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(36800-975) , pack(36800-975) , label(36800-975)