MedPath

Revitalize Energizing Eye Drops

Drug Facts

Approved
Approval ID

518aac87-1642-4b2f-bca1-b74d21261eea

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jul 31, 2025

Manufacturers
FDA

Revitalize Energy Inc.

DUNS: 063414745

Products 1

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

Naphazoline Hydrochloride ,Propylene Glycol

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code82864-001
Application NumberM018
Product Classification
M
Marketing Category
C200263
G
Generic Name
Naphazoline Hydrochloride ,Propylene Glycol
Product Specifications
Route of AdministrationOPHTHALMIC
Effective DateJuly 31, 2025
FDA Product Classification

INGREDIENTS (11)

BENZALKONIUM CHLORIDEInactive
Code: F5UM2KM3W7
Classification: IACT
BORIC ACIDInactive
Code: R57ZHV85D4
Classification: IACT
BORNEOLInactive
Code: M89NIB437X
Classification: IACT
CAFFEINEInactive
Code: 3G6A5W338E
Classification: IACT
CAMPHOR (SYNTHETIC)Inactive
Code: 5TJD82A1ET
Classification: IACT
MENTHOL, UNSPECIFIED FORMInactive
Code: L7T10EIP3A
Classification: IACT
POTASSIUM ASPARTATEInactive
Code: OC4598NZEQ
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
TAURINEInactive
Code: 1EQV5MLY3D
Classification: IACT
NAPHAZOLINE HYDROCHLORIDEActive
Quantity: 0.03 g in 100 mL
Code: MZ1131787D
Classification: ACTIB
PROPYLENE GLYCOLActive
Quantity: 1 g in 100 mL
Code: 6DC9Q167V3
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/30/2025

Product label

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 1/23/2023

Uses

  • Temporarily relieves burning and irritation due to dryness of the eye
  • Relieves redness of the eye due to minor eye irritations

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/30/2025

Active Ingredient Purpose

Naphozoline Hydrochloride 0.03% Redness Reliver
Propylene Glycol 1.0% Lubricant

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 1/23/2023

WARNINGS SECTION

LOINC: 34071-1Updated: 1/23/2023

Warnings

For external use only

For use in the eyes only, do not drink

Ask a doctor before use if you have narrow angle glaucoma

When using this product

• Do not touch tip of container to any surface to avoid contamination
• Replace each cap after each use
• Do not use if solution changes color or becomes cloudy
• Overuse may cause more eye redness
• Pupils may become enlarged temporarily
• Remove contact lenses before use

Stop Use and ask a doctor if
• You feel eye pain
• Changes in vision occur
• Redness or irritation of the eyes lasts
• Condition worsens or lasts more than 72 hours

Keep out of reach of children
• If swallowed, get medical help or contact a Poison Control center right away

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 1/23/2023

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 1/23/2023

Directions

Put 1 or 2 drops in the affected eye(s) up to 4 times daily
Tightly screw on cap to seal after use

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 3/14/2025

Other information

Store at 20 - 25°C (68 -77°F)

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 1/23/2023

Inactive ingredients

Benzalkonium Chloride, Boric Acid, Borneol, Caffeine, Camphor, menthol, potassium l-aspartate, purified water, Taurine

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