Label: BOUTON- water rinse

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: 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 Information

Updated July 5, 2010

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients                                                      Purpose:

    Purified water USP98.6%............................................Eye Wash

    Purpose:

    Eye Wash

  • INDICATIONS & USAGE

    Uses: For flushing/irrigating the eyes to remove loose foreign material, air pollutants, chlorinated water and to refresh irritated or tired eyes.

  • WARNINGS

    Warning:

    For external use only

  • DO NOT USE

    Do Not Use:

    • for injection
    • with contact lenses
    • if solution changes color or gets cloudy
    • if eye is lacerated or object is embedded
    • if twist top is broken or missing
  • STOP USE


    Stop use and consult a doctor if you have:

    • changes in vision
    • continued redness in or near the eyes
    • eye pain
    • if condition worsens or persists

  • 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.

  • DOSAGE & ADMINISTRATION

    Directions:

    • twist top to open
    • flush the affected eye as needed, controlling the rate of flow of solution by pressure on the bottle
    • discard bottle after use, single use only
  • STORAGE AND HANDLING

    Other Information:

    Store out of direct sunlight between 15 degrees C and 30 degrees C (59 degrees F - 86 degrees F)

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Potassium phosphate monobasic, sodium chloride USP, sodium hydroxide.

  • QUESTIONS

    Questions:

    800-426-1881 www.hlbouton.com eyewear@hlbouton.com

    Manufactured in Singapore for H.L. Bouton Co. Wareham, Ma. 02571

  • PRINCIPAL DISPLAY PANEL

    image of bottle label 473ml

  • PRINCIPAL DISPLAY PANEL

    image of carton label 473ml

  • INGREDIENTS AND APPEARANCE
    BOUTON   EYE WASH
    water rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68276-004
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water98.6 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68276-004-0212 in 1 CARTON
    1NDC:68276-004-01473 mL in 1 BOTTLE
    2NDC:68276-004-0412 in 1 CARTON
    2NDC:68276-004-03944 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34901/15/2010
    Labeler - Aaxis Pacific (751370305)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!