ADVANCED RELIEF- dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid
American Sales Company

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CareOne Advance Relief Eye Drop (PLD)

Active Ingredient

Dextran 70 0.1%

Polyethylene Glycol 400 1%

Povidone 1%

Tetrahydrozoline HCl 0.5%

Purpose

Lubricant

Redness reliever

Use

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 using 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 cause increased redness of the eye
remove contact lenses 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 right away.

Directions

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

Other information

store at 15° to 30°C (59°F to 86°F)

Inactive ingredients

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

package label

Advanced Relief

carton

ADVANCED RELIEF
dextran 70, polyethylene glycol 400, povidone, tetrahydrozoline hcl liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:41520-532
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.5 mg in 1 mL
DEXTRAN 70 (UNII: 7SA290YK68) (DEXTRAN 70 - UNII:7SA290YK68)	DEXTRAN 70	1 mg in 1 mL
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) (POLYETHYLENE GLYCOL 400 - UNII:B697894SGQ)	POLYETHYLENE GLYCOL 400	10 mg in 1 mL
POVIDONE (UNII: FZ989GH94E) (POVIDONE - UNII:FZ989GH94E)	POVIDONE	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:41520-532-05	1 in 1 BOX	09/11/2011
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M018	09/07/2011

Labeler - American Sales Company (809183973)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(41520-532) , pack(41520-532) , label(41520-532)

Revised: 12/2024

Document Id: 2abada7d-4106-54ca-e063-6394a90a3d4f

Set id: 806197fc-5d1f-4e88-b6f2-76034042cac8

Version: 5

Effective Time: 20241231

American Sales Company