MedPath

BEPPEN FRESH DROP

Approved
Approval ID

9a272dfd-7cba-474c-80d2-81cfa8d2eb2e

Product Type

OTC ANIMAL DRUG LABEL

Effective Date

Sep 2, 2025

Manufacturers
FDA

SUPERBLIC Inc.

DUNS: 695647063

Products 1

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

SODIUM HYALURONATE

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code86243-0002
Product Classification
G
Generic Name
SODIUM HYALURONATE
Product Specifications
Route of AdministrationTOPICAL
Effective DateSeptember 2, 2025
FDA Product Classification

INGREDIENTS (3)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
TREHALOSEInactive
Code: B8WCK70T7I
Classification: IACT
SODIUM HYALURONATEActive
Quantity: 0.18 g in 100 mL
Code: YSE9PPT4TH
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/3/2025

image description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/28/2025

Apply 2-3 drops of this product to your eye and wipe away any foreign matter with a soft cloth.

After wiping, reapply 1-2 drops.

Repeat 2-3 times if necessary.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/29/2025

SODIUM HYALURONATE

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 8/28/2025

SODIUM CHLORIDE

DIBASIC POTASSIUM PHOSPATE

SODIUM BENZOATE

WATER

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/28/2025

Pet eye care: cleaning and removal of irritants for dogs and cats

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 8/28/2025

Keep out of reach of children

WARNINGS SECTION

LOINC: 34071-1Updated: 8/28/2025

Precautions
A. Side Effects

  1. If red spots, swelling, itchiness, or irritation occur during use, consult a veterinarian.

B. Contraindications

  1. Do not use on wounds, eczema, or other skin abnormalities.

C. Other Precautions

  1. Close the cap after use.
  2. Keep out of reach of infants and children.
  3. Do not store in extremely hot or cold places or in direct sunlight.

D. If foreign substances appear, do not use and discard immediately.

E. Store in a cool place out of direct sunlight or in the refrigerator.
F. This product is a veterinary drug and cannot be used for therapeutic purposes.
G. If ophthalmic treatment is required, consult a veterinarian before use.
H. Be careful not to let the container's opening touch your hands or eyes. Do not contaminate it. Do not use if contaminated.
I. When opening, be careful not to let the tip of the container come into direct contact with your eyes, as the cut edge may be sharp.
J. After opening, it is recommended to discard the first 1-2 drops before use.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 3/25/2024

For external use only

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