drug facts

drug facts
SPL v11
SPL
SPL Set ID 3c11285a-7e86-4b47-b1ee-e7d59858087d
Route
ophthalmic
Published
Effective Date 2024-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hypromellose, unspecified (5 mg) naphazoline (0.3 mg)
Inactive Ingredients
benzalkonium chloride boric acid edetate disodium water sodium borate sodium chloride hydrochloric acid sodium hydroxide

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2010-09-02 Until 2022-07-31

Purpose

Lubricant Redness reliever

Description

Hypromellose (0.5%) Naphazoline hydrochloride (0.03%)


Medication Information

Warnings

For external use only

Uses
  • temporary relief of redness and discomfort due to:
    • minor eye irritations
    • exposure to wind or sun
    • dryness of the eye
  • prevents further irritation
Purpose

Lubricant

Redness reliever

Directions
  • instill 1 to 2 drops in the affected eye(s) up to four times daily
Other Information
  • store at 15–25 °C (59–77 °F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle
Inactive Ingredients

benzalkonium chloride, boric acid, edetate disodium, sodium borate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Description

Hypromellose (0.5%) Naphazoline hydrochloride (0.03%)

Do Not Use
  • if solution changes color or becomes cloudy
Active Ingredients

Hypromellose (0.5%)

Naphazoline hydrochloride (0.03%)

Questions Or Comments?

[phone icon] Call: 1-800-553-5340

When Using This Product
  • do not touch tip of container to any surface to avoid contamination
  • do not overuse as it may produce increased redness of the eye
  • pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after use
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 right away.

Ask A Doctor Before Use If You Have
  • narrow angle glaucoma
Package/label Principal Display Panel

BAUSCH + LOMB

ADVANCED

Eye Relief ®

Maximum

Redness

REDNESS RELIEVER/

LUBRICANT EYE DROPS

  • Maximum strength

    redness reliever
  • Moisturizes and

    comforts

STERILE 0.5 FL OZ (15 mL)

3843903

AB55411A


Structured Label Content

Warnings

For external use only

Uses
  • temporary relief of redness and discomfort due to:
    • minor eye irritations
    • exposure to wind or sun
    • dryness of the eye
  • prevents further irritation
Purpose

Lubricant

Redness reliever

Directions
  • instill 1 to 2 drops in the affected eye(s) up to four times daily
Other Information (Other information)
  • store at 15–25 °C (59–77 °F)
  • keep tightly closed
  • use before expiration date marked on the carton and bottle
Inactive Ingredients (Inactive ingredients)

benzalkonium chloride, boric acid, edetate disodium, sodium borate, sodium chloride, water for injection. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Do Not Use (Do not use)
  • if solution changes color or becomes cloudy
Active Ingredients (Active ingredients)

Hypromellose (0.5%)

Naphazoline hydrochloride (0.03%)

Questions Or Comments? (Questions or comments?)

[phone icon] Call: 1-800-553-5340

When Using This Product (When using this product)
  • do not touch tip of container to any surface to avoid contamination
  • do not overuse as it may produce increased redness of the eye
  • pupils may become enlarged temporarily
  • remove contact lenses before using
  • replace cap after use
Stop Use and Ask A Doctor If (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 (Keep out of reach of children)

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

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • narrow angle glaucoma
Package/label Principal Display Panel (Package/Label Principal Display Panel)

BAUSCH + LOMB

ADVANCED

Eye Relief ®

Maximum

Redness

REDNESS RELIEVER/

LUBRICANT EYE DROPS

  • Maximum strength

    redness reliever
  • Moisturizes and

    comforts

STERILE 0.5 FL OZ (15 mL)

3843903

AB55411A


Advanced Ingredient Data


Raw Label Data

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