REGENEREYES LITE- 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.

----------

(in each drop)
Glycerin, 0.4%

Eye lubricant

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.

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

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

d-MAPPS TM and 0.9% Sodium Chloride USP.

Store at Room Temperature.

Questions? 1 800 781 0818

R-Eyes LITE Carton with Drug Facts R-Eyes LITE Primary Bottle Label

REGENEREYES LITE
regenereyes solution/ drops

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:82305-002
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX)	GLYCERIN	0.4

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82305-002-01	1 in 1 CARTON	04/29/2021	04/29/2021
1		3 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	04/29/2021	04/29/2021

Labeler - Regenerative Processing Plant, LLC (079446889)

Name	Address	ID/FEI	Business Operations
Establishment
Regenerative Processing Plant, LLC		079446889	manufacture(82305-002) , label(82305-002) , pack(82305-002)

Revised: 9/2022

Document Id: e802dac6-b648-3287-e053-2a95a90aeefa

Set id: d1243811-c094-53f9-e053-2995a90abd74

Version: 2

Effective Time: 20220906

Regenerative Processing Plant, LLC