SIGNATURE CARE LUBRICANT EYE DROPS LONG LASTING- polyethylene glycol 400, propylene glycol solution

Signature Care Lubricant Eye Drops Long Lasting by

Drug Labeling and Warnings

Signature Care Lubricant Eye Drops Long Lasting by is a Otc medication manufactured, distributed, or labeled by Better Living Brands, LLC, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

polyethylene glycol 400 0.4%

propylene glycol 0.3%

Purpose

Lubricant

Lubricant

Uses

• for the temporary relief of burning and irritation due to dryness of the eye

Warnings

for external use only

Do not use

• if this product changes color or becomes cloudy
• if you are sensitive to any ingredient in this product

When using this product

• do not touch tip of container to any surface to avoid contamination
• replace cap after each use

Stop use and ask a doctor if

• you feel eye pain
• changes in vision occur
• redness or irritation of the eye(s), gets worse or lasts more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away

Directions

• Instill 1 or 2 drops in the affected eye(s) as needed.
• Children under 6 years of age: ask a doctor

Other information

• RETAIN THIS CARTON FOR FUTURE REFERENCE
• Store at room temperature

Inactive ingredients

Benzalkonium chloride as preservative, boric acid, calcium chloride, hypromellose, magnesium chloride, potassium chloride, purified water, sodium borate, sodium chloride, zinc chloride.

Signature Care Lubricant Eye Drops Long Lasting 15mL

INGREDIENTS AND APPEARANCE

SIGNATURE CARE LUBRICANT EYE DROPS LONG LASTING 
polyethylene glycol 400, propylene glycol solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 21130-756
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	0.4 g  in 100 mL
PROPYLENE GLYCOL (UNII: 6DC9Q167V3) (PROPYLENE GLYCOL - UNII:6DC9Q167V3)	PROPYLENE GLYCOL	0.3 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
CALCIUM CHLORIDE (UNII: M4I0D6VV5M)
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
ZINC CHLORIDE (UNII: 86Q357L16B)
WATER (UNII: 059QF0KO0R)
HYPROMELLOSES (UNII: 3NXW29V3WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21130-756-01	1 in 1 BOX	04/02/2018
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 Drug	M018	04/02/2018

Labeler - Better Living Brands, LLC (009137209)

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

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(21130-756) , pack(21130-756) , label(21130-756)