GLITCH ADVANCED RELIEF EYE DROPS- polyethylene glycol 400, tetrahydrozoline hcl solution/ drops
Misemer Pharmaceutical, Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Glitch Advanced Relief Eye Drops 15mL (PLD)

Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCI 0.05%

Purposes

Lubricant

Redness reliever

Uses

relieves redness of the eye due to minor eye irritations
as a lubricant to prevent further irritation or to relieve dryness of the eye

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.

Directions

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

Other information

store at 15º-30ºC (59º-86ºF)

Inactive ingredients

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

Questions or comments?

Call 1-662-993-9625 Mon-Fri

9 am - 5 pm EST

Glitch Advanced Relief Eye Drops 15mL

GLITCH ADVANCED RELIEF EYE DROPS
polyethylene glycol 400, tetrahydrozoline hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0276-0801
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	1 g in 100 mL
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
SODIUM BORATE (UNII: 91MBZ8H3QO)
DEXTRAN 70 (UNII: 7SA290YK68)
POVIDONE (UNII: FZ989GH94E)
WATER (UNII: 059QF0KO0R)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0276-0801-15	1 in 1 BOX	08/21/2023
1		15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	08/21/2023

Labeler - Misemer Pharmaceutical, Inc (784121365)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(0276-0801) , pack(0276-0801) , label(0276-0801)

Revised: 8/2023

Document Id: 03778509-3375-2168-e063-6294a90a9505

Set id: 03778509-3374-2168-e063-6294a90a9505

Version: 1

Effective Time: 20230821

Misemer Pharmaceutical, Inc