Regener-Eyes by Regenerative Processing Plant, LLC / Regenerative Process Plant

Regener-Eyes by

Drug Labeling and Warnings

Regener-Eyes by is a Otc medication manufactured, distributed, or labeled by Regenerative Processing Plant, LLC, Regenerative Process Plant. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

REGENER-EYES LITE- regenerative processing plant solution/ drops 
Regenerative Processing Plant, 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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Active Ingredient

Glycerin 0.4%

Eye Lubricant

Uses

• For the temporary relief of burning and irritation due to dryness of the eye.
• For use as a lubricant to prevent further irritation or to relieve dryness of the eye.
• For use as a protectant against further irritation or to relieve dryness of the eye.

Warnings

Warnings External Use Only

• To avoid contamination, do not touch tip of the bottle closure to any surface(s) including the eye or the skin.
• Do not use 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.
• Condition worsens or persists for more than 72 hours.

Keep out of reach of children

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

Directions

Directions Instill 1 to 4 drops, one to four times per day in each eye, or as recommended by your eye care professional.

Inactive Ingredient

Tonicity Solution TM; Sterile Water.

Other information

• Store at Room Temperature.

Questions?

Questions? (800) 781-0818

Artwork

REGENER-EYES  LITE
regenerative processing plant solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82305-004
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	15 mg  in 3 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	15 mg  in 3 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82305-004-01	3 in 1 BOX	08/24/2022	08/30/2022
1		3 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	08/24/2022	08/30/2022

Labeler - Regenerative Processing Plant, LLC (079446889)

Establishment
Name	Address	ID/FEI	Business Operations
Regenerative Process Plant		079446889	manufacture(82305-004) , label(82305-004) , pack(82305-004) , analysis(82305-004)

Revised: 8/2022

Document Id: e7773258-9e14-140f-e053-2995a90a232a

34390-5

Set id: e6993ab7-d042-6d71-e053-2995a90a6a14

Version: 3

Effective Time: 20220830