FOSTER AND THRIVE DRY EYE RELIEF- polyethylene glycol 400 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 Dry Eye Relief 15mL (PLD)

Active ingredient

Polyethylene glycol 400 1%

Purpose

Lubricant

Uses

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

Warnings

For external use only

Do not use this product if

solution changes color or becomes cloudy

When using this product

to avoid contamination, do not touch tip of container to any surface. Replace cap after using.
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) as needed

Other information

store at 15°-30°C (59°-86°F)

Inactive ingredients

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

Questions or comments?

Call 833-358-6431

Monday to Friday

9:00am to 7:00pm EST

Foster & Thrive Dry Eye Relief 15mL

FOSTER AND THRIVE DRY EYE RELIEF
polyethylene glycol 400 solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70677-1157
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

Ingredient Name	Strength
Inactive Ingredients
DEXTROSE (UNII: IY9XDZ35W2)
WATER (UNII: 059QF0KO0R)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS (UNII: KH7I04HPUU)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POTASSIUM CHLORIDE (UNII: 660YQ98I10)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:70677-1157-1	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(70677-1157) , pack(70677-1157) , label(70677-1157)

Revised: 7/2023

Document Id: 00766a7b-7986-dd15-e063-6394a90af9ac

Set id: 0018ade9-5856-db6c-e063-6394a90a2ccf

Version: 2

Effective Time: 20230713

Strategic Sourcing Services LLC