FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS- polyethylene glycol 400, tetrahydrozoline hcl solution/ drops
Strategic Sourcing Services LLC

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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Foster & Thrive Advanced Relief Eye Drops 15mL (PLD)

Active ingredients

Polyethylene glycol 400 1%

Tetrahydrozoline HCl 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 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 (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 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call 833-358-6431

Monday to Friday

9:00am to 7:00pm EST

Foster & Thrive Advanced Relief Eye Drop 15mL

FOSTER AND THRIVE ADVANCED RELIEF EYE DROPS
polyethylene glycol 400, tetrahydrozoline hcl solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-1158
Route of Administration	OPHTHALMIC

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-1158-1	1 in 1 BOX	07/09/2023
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	07/09/2023

Labeler - Strategic Sourcing Services LLC (116956644)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(70677-1158) , pack(70677-1158) , label(70677-1158)

Revised: 7/2023

Document Id: 007630de-b0ee-6383-e063-6394a90a9c7d

Set id: 0019cd99-b245-2ffc-e063-6294a90a9f27

Version: 2

Effective Time: 20230713

Strategic Sourcing Services LLC