Your browser does not support JavaScript! ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF (NAPHAZOLINE HYDROCHLORIDE AND HYPROMELLOSE) SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED]
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ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF (naphazoline hydrochloride and hypromellose) solution/ drops
[Bausch & Lomb Incorporated]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Active Ingredients

Hypromellose (0.5%)

Naphazoline hydrochloride (0.03%)

Purpose

Lubricant

Redness reliever

Uses

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

Warnings

Do not use

  • if solution changes color or becomes cloudy

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
  • 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

Keepout of reach of children.

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

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 (0.01%), boric acid, edetate disodium, purified water, sodium borate, sodium chloride. Hydrochloric acid and/or sodium hydroxide may be used to adjust pH.

Questions or Comments?

Toll Free Product Information or to Report a Serious Side Effect Associated with use of this product Call: 1-800-553-5340

Package/Label Principal Display Panel

Bausch & Lomb AER Redness carton

Bausch & Lomb

Advanced Eye Relief™

Redness

Maxium Relief

Redness Reliever/Lubricant Eye Drops

Relieves dry, burning and irritated eyes

Long lasting comfort

0.5 FL OZ (15mL)

ADVANCED EYE RELIEF/ REDNESS MAXIMUM RELIEF 
naphazoline hydrochloride and hypromellose solution/ drops
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:24208-450
Route of AdministrationOPHTHALMICDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
NAPHAZOLINE HYDROCHLORIDE (NAPHAZOLINE) NAPHAZOLINE HYDROCHLORIDE5 mg  in 1 mL
HYPROMELLOSE (HYPROMELLOSE) HYPROMELLOSE0.3 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
BENZALKONIUM CHLORIDE 
BORATE ION 
SODIUM BORATE 
SODIUM CHLORIDE 
WATER 
EDETATE DISODIUM 
HYDROCHLORIC ACID 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24208-450-151 in 1 CARTON
115 mL in 1 BOTTLE, DROPPER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34909/02/2010
Labeler - Bausch & Lomb Incorporated (196603781)
Establishment
NameAddressID/FEIBusiness Operations
Bausch & Lomb Incorporated114406598MANUFACTURE

Revised: 9/2010
 
Bausch & Lomb Incorporated

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