DG HEALTH DRY EYE RELIEF- glycerin, hypromellose, polypropylene glycol 400 solution

DG Health Dry Eye Relief by

Drug Labeling and Warnings

DG Health Dry Eye Relief by is a Otc medication manufactured, distributed, or labeled by Dolgencorp LLC, K.C. Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Glycerin 0.2%

Hypromellose 0.2%

Polyethylene glycol 400 1%

PURPOSE

Purpose

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

Hypromellose.............Lubricant

Polyethylene glycol 400.............Lubricant

INDICATIONS & USAGE

Uses

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

WARNINGS

Warnings

For external use only

Do not use this product if solution changes color or becomes cloudy

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

When using this product

• to avoid contamination, do not touch tip of container to any surface
• replace cap after using. Keep container tightly closed
• remove contact lens before using

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

If pregnant or breast feeding, ask a healh professional before use

DOSAGE & ADMINISTRATION

Directions

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

OTHER SAFETY INFORMATION

Other information

• RETAIN THIS CARTON FOR FUTURE REFERENCE
• Store at 15º-30ºC (59º-86ºF)

INACTIVE INGREDIENT

Inactive ingredients

dextrose, sodium chloride, potassium chloride, sodium phosphate monobasic, sodium phosphate dibasic, sodium bicarbonate, sodium citrate, edetate disodium, benzalkonium chloride, purified water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DG HEALTH DRY EYE RELIEF 
glycerin, hypromellose, polypropylene glycol 400 solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55910-362
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.2 g  in 100 mL
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) (HYPROMELLOSE, UNSPECIFIED - UNII:3NXW29V3WO)	HYPROMELLOSE, UNSPECIFIED	0.2 g  in 100 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
DEXTROSE (UNII: IY9XDZ35W2)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
SODIUM PHOSPHATE, MONOBASIC, UNSPECIFIED FORM (UNII: 3980JIH2SW)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
EDETATE DISODIUM (UNII: 7FLD91C86K)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
WATER (UNII: 059QF0KO0R)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55910-362-01	1 in 1 CARTON	01/27/2020
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	01/27/2020

Labeler - Dolgencorp LLC (068331990)

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

Establishment
Name	Address	ID/FEI	Business Operations
K.C. Pharmaceuticals, Inc.		174450460	manufacture(55910-362) , pack(55910-362) , label(55910-362)