Retaine Allergy Solution/ Drops
FDA Label NDC 54799-920

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Ocusoft Llc for the product Retaine Allergy (NDC 54799-920). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding use, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Use

temporarily relieves itchy eyes due to pollen, ragweed, grass, animal hair and dander

Warnings

For external use only

Do Not Use

  • if solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product
  • to treat contact lens related irritation

When Using This Product

  • do not touch tip of container to any surface to avoid contamination
  • remove contact lenses before use
  • wait at least 10 minutes before reinserting contact lenses after use
  • do not wear contact lens if your eye is red

Stop Use And Ask A Doctor If

you experience:

  • eye pain
  • changes in vision
  • increased redness of the eye
  • itching worsens or lasts for more than 72 hours

Keep Out Of Reach Of Children.

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

Directions

■ adults and children 2 years of age and older:

  • put 1 drop in the affected eye(s) once daily, no more than once per day
  • if using other ophthalmic products while using this product, wait at least 5 minutes between each product
  • replace cap after each use

    • ■ children under 2 years of age:
            consult a doctor 

Other Information

  • only for use in the eye
  • store between 2° to 25°C (36° to 77°F)

Inactive Ingredients

benzalkonium chloride 0.01%, dibasic sodium phosphate, edetate disodium, hydrochloric acid/sodium hydroxide (adjust pH), povidone, sodium chloride and water for injection.

Questions?

Call (800) 233-5469
M-F 8:30 AM - 5:30 PM CST or
visit www.ocusoft.com

Principal Display Panel

Retaine® 
NDC-54799-25 ALLERGY

OCuSOFT

EYE ALLERGY
ITCH RELIEF

ONCE DAILY

Olopatadine Hydrochloride
Ophthalmic Solution,
USP 0.2% Antihistamine

2.5 mL (0.085 fl oz)          Sterile

Only for use in the eye. Store between
2°C to 25°C (36°F to 77°F)

TAMPER EVIDENT: Do not use if ring
at bottom of cap is broken or missing
at the time of purchase

Manufactured for:
OCuSOFT Inc., Rosenberg, TX 77471
Product of India

M.L. No: G/28/1704

20041115

LOT:

EXP:

20041115

R04/24

Label (Label)

Label (Label)

Retaine®
ALLERGY

OCuSOFT®

Eye Allergy
Itch Relief

Olopatadine Hydrochloride
Ophthalmic Solution, USP 0.2%

Antihistamine

ONCE DAILY
Works in Minutes

Relief from Allergens:
· Pet Dander · Pollen
· Grass · Ragweed

Sterile

2.5mL (0.085 fl oz)

OCuSOFT


TAMPER EVIDENT:
Do not use if ring at bottom of
cap is broken or missing at
the time of purchase.

Original Prescription Strength

For Ages 2
and Older
30 DAY
SUPPLY

Once Daily Eye
Allergy Itch
Relief. Works in
Minutes.

Fill Line

Actual Size

OCuSOFT

Manufactured for OCuSOFT Inc.
Rosenberg, TX 77471 USA
(800) 233-5469 wwwocusoft.com
© 2024 OCuSOFT Inc.
® marks owned by OCuSOFT inc.
Product of India

777-3-96 R04/24




Carton (Carton)

Carton (Carton)

* Please review the disclaimer below.