SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF- glycerin, naphazoline hydrochloride liquid

Signature Care Eye Drops Redness and Dry Eye Relief by

Drug Labeling and Warnings

Signature Care Eye Drops Redness and Dry Eye Relief by is a Otc medication manufactured, distributed, or labeled by Better Living Brands LLC, KC Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Glycerin 0.25%

Naphazoline hydrochloride 0.012%

Purposes

Glycerin  Lubricant

Naphazoline hydrochloride   Redness reliever

Uses

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

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
• changes in vision occur
• redness or irritation of the eye lasts
• condition worsens
• symptoms last for more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

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

Other information

• store at room temperature
• remove contact lenses before using

Inactive ingredients

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

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE EYE DROPS REDNESS AND DRY EYE RELIEF 
glycerin, naphazoline hydrochloride liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-703
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.25 g  in 100 mL
NAPHAZOLINE HYDROCHLORIDE (UNII: MZ1131787D) (NAPHAZOLINE - UNII:H231GF11BV)	NAPHAZOLINE HYDROCHLORIDE	0.012 g  in 100 mL

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-703-01	1 in 1 CARTON	10/05/2018
1		15 mL in 1 BOTTLE, PLASTIC; 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	10/05/2018

Labeler - Better Living Brands LLC (009137209)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Establishment
Name	Address	ID/FEI	Business Operations
KC Pharmaceuticals, Inc.		174450460	manufacture(21130-703) , pack(21130-703) , label(21130-703)