Label: SALINAAX EYE WASH AND SKIN FLUSH- 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 March 11, 2011

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

View All Sections
  • ACTIVE INGREDIENT

    Active Ingredients:
    Purified water USP 98.6%

  • PURPOSE

    Purpose:
    Eye wash and skin flush
  • INDICATIONS & USAGE

    Uses: For irrigating the eyes to remove loose foreign material, air pollutants, chlorinated water and for flushing the skin.

  • WARNINGS

    Warnings: For external use only. To avoid contamination, do not touch tip of container to any surface. Do not reuse. Once opened, discard, do not transfer to other bottle containers. If you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists, consult a doctor, obtain immediate medical treatment for all open wounds in or near the eyes. If solution changes color or becomes cloudy, do not use.
  • DO NOT USE

    Do Not Use:For injection, with contact lenses, If eye is lacerated or object is embedded, If twist top is broken or missing.
  • STOP USE

    If solution changes color or becomes cloud, do not use.
  • 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.
  • 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.

  • PRINCIPAL DISPLAY PANEL

    image of label
    Salinaax
    Tamper-evident ca do not use if twist-off or is broken or missing
    Preservative free
    Eye Wash and Skin Flush
    Single Use Only
    Sterile Buffered Isotonic Solution
    5fl.oz (148ml)
    Compliance: Ansi/isea
    (As personal eye wash only)
    AAXIS Excelling in healthcare solutions
  • INGREDIENTS AND APPEARANCE
    SALINAAX  EYE WASH AND SKIN FLUSH
    water rinse
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68276-005
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Water (UNII: 059QF0KO0R) (Water - UNII:059QF0KO0R) Water98.6 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Potassium phosphate, monobasic (UNII: 4J9FJ0HL51)  
    Sodium chloride (UNII: 451W47IQ8X)  
    Sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68276-005-01148 mL in 1 BOTTLE
    2NDC:68276-005-02236 mL in 1 BOTTLE
    3NDC:68276-005-03472 mL in 1 BOTTLE
    4NDC:68276-005-04944 mL in 1 BOTTLE
    5NDC:68276-005-0515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/11/2011
    Labeler - Aaxis Pacific (751370305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Opto Pharm Pte Ltd595239682manufacture
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!