RegenerEyes by Regenerative Processing Plant, LLC

RegenerEyes by

Drug Labeling and Warnings

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

Drug Details [pdf]

REGENEREYES PRO- regenereyes 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

(in each drop)

Glycerin, 0.5%

Purpose

Eye lubricant

Uses

For the temporary relief of burning and irritation due to dryness of the eye.
For the temporary relief of discomfort due to minor irritation of the eye or to exposure to wind or sun.

For use as a protectant against further irritation or to relieve dryness of the eye.

For use as a lubricant to prevent further irritation or to relieve dryness of the eye.

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.

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.

Warnings

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

Directions

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

Inactive Ingredients

d-MAPPS TM and 0.9% Sodium Chloride USP.

Storage

Store at refrigerated conditions once the bottle closure is activated to the open position.

Questions?

1 800 781 0818

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REGENEREYES  PRO
regenereyes solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82305-001
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.5

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82305-001-01	3 in 1 CARTON	03/31/2022
1		3 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	03/31/2022	04/29/2022

Labeler - Regenerative Processing Plant, LLC (079446889)

Establishment
Name	Address	ID/FEI	Business Operations
Regenerative Processing Plant, LLC		079446889	manufacture(82305-001) , label(82305-001) , pack(82305-001)

Revised: 9/2022

Document Id: e7a0011c-193c-7f15-e053-2a95a90a415c

34390-5

Set id: ceca8000-d22f-4b44-e053-2995a90a4322

Version: 2

Effective Time: 20220901