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Refresh RELIEVA PF

REFRESH RELIEVA PF Drug Facts

Approved
Approval ID

d5d3df4a-a311-4f2d-9a24-edfec1a6c9f9

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Aug 22, 2025

Manufacturers
FDA

Allergan, Inc.

DUNS: 144796497

Products 2

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Carboxymethylcellulose sodium and Glycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0023-4515
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Carboxymethylcellulose sodium and Glycerin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (12)

CARBOXYMETHYLCELLULOSE SODIUMActive
Quantity: 5 mg in 1 mL
Code: K679OBS311
Classification: ACTIB
GLYCERINActive
Quantity: 10 mg in 1 mL
Code: PDC6A3C0OX
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
ERYTHRITOLInactive
Code: RA96B954X6
Classification: IACT
LEVOCARNITINEInactive
Code: 0G389FZZ9M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Carboxymethylcellulose sodium and Glycerin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0023-9537
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Carboxymethylcellulose sodium and Glycerin
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateAugust 22, 2025
FDA Product Classification

INGREDIENTS (12)

CARBOXYMETHYLCELLULOSE SODIUMActive
Quantity: 5 mg in 1 mL
Code: K679OBS311
Classification: ACTIB
GLYCERINActive
Quantity: 10 mg in 1 mL
Code: PDC6A3C0OX
Classification: ACTIB
CALCIUM CHLORIDEInactive
Code: M4I0D6VV5M
Classification: IACT
ERYTHRITOLInactive
Code: RA96B954X6
Classification: IACT
LEVOCARNITINEInactive
Code: 0G389FZZ9M
Classification: IACT
MAGNESIUM CHLORIDEInactive
Code: 02F3473H9O
Classification: IACT
POTASSIUM CHLORIDEInactive
Code: 660YQ98I10
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM LACTATEInactive
Code: TU7HW0W0QT
Classification: IACT
HYALURONATE SODIUMInactive
Code: YSE9PPT4TH
Classification: IACT
HYDROCHLORIC ACIDInactive
Code: QTT17582CB
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/22/2025

PRINCIPAL DISPLAY PANEL

NDC 0023 9537 05
Refresh®
RELIEVA™ PF
Lubricates and Protects
Recommended for Sensitive Eyes
5 Vials 0.01 fl oz (0.4 mL) Sterile

![NDC 0023 9537 05 Refresh® RELIEVA™ PF Lubricates and Protects Recommended for Sensitive Eyes 5 Vials 0.01 fl oz (0.4 mL) Sterile ](/dailymed/image.cfm?name=refresh-relieva-preservative-free-unit- dose-03.jpg&id=896013)

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/22/2025

Uses

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

  • May be used as a protectant against further irritation.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/22/2025

Active ingredients

Carboxymethylcellulose sodium 0.5%

Glycerin 1.0%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/22/2025

Purpose

Eye lubricant

Eye lubricant

WARNINGS SECTION

LOINC: 34071-1Updated: 8/22/2025

Warnings

*For external use only.

*To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard.

*Do not touch unit-dose tip to eye.

If solution changes color* or becomes cloudy****, do not use.******

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.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 8/22/2025

Directions

To open,TWIST AND PULL TAB TO REMOVE.

  • Instill 1 or 2 drops in the affected eye(s) as needed and discard container

  • *Follow your eye doctor’s instructions if you are using this product after an eye surgery (e.g., LASIK) to relieve eye dryness and discomfort.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 8/22/2025

Other information

  • Use only if single-use container is intact.

  • Use before expiration date marked on container.

  • Store at 59°-77°F (15°-25°C).

  • Protect from sunlight.

  • RETAIN THIS CARTON FOR FUTURE REFERENCE.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/22/2025

Inactive ingredients

Calcium chloride dihydrate; erythritol; levocarnitine; magnesium chloride hexahydrate; potassium chloride; purified water; sodium lactate; and sodium hyaluronate. May contain hydrochloric acid and/or sodium hydroxide (to adjust pH).

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/22/2025

Questions or comments?

![Telephone icon and phone number](/dailymed/image.cfm?name=refresh-relieva- preservative-free-unit-dose-01.jpg&id=896013)

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Refresh RELIEVA PF - FDA Drug Approval Details