Label: NATURES TEARS solution/ drops

  • 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 April 20, 2011

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  • Active ingredient

    Hypromellose

  • Purpose

    Lubricant

  • Keep Out of Reach of Children

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

  • Uses

    ° relieves dryness of the eye

    ° prevents further irritation

  • Warnings

    Do not use if solution changes color or becomes cloudy

    When using this product:

    ° do not touch tip of container to any surface to avoid contamination

    ° 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

  • Directions

    ° instill 1 or 2 drops in the affected eye(s) as needed

  • Other Information

    ° store at 15° - 30°C (59° - 85°F)

    ° keep tightly closed

    FOR USE IN THE EYES ONLY

  • Inactive ingredients

    dibasic sodium phosphate, edetate disodium, monobasic sodium phosphate,

    potassium chloride, sodium chloride, purified water.

    Hydrochloric acid and/or sodium hydroxide may be added to adjust pH.

    Preservative added: benzalkonium chloride 0.01%

  • Questions of Comments?

    Call 1-800-645-2158

    9 am - 5 pm ET, Monday-Friday.

    Serious side effects associated with use of this product may be reported to this number.

    Distributed by:

    Rugby Laboratories, Inc.

    Duluth, GA 30097

    Repackaged by:

    Rebel Distributors Corp.

    Thousand Oaks, CA 91320

  • Package/Label Principal Display Panel

    Nature's Tears 0.4%

  • INGREDIENTS AND APPEARANCE
    NATURES TEARS 
    natures tears solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-930(NDC:0536-6237)
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HYPROMELLOSE 2910 (3 MPA.S) (UNII: 0VUT3PMY82) (HYPROMELLOSES - UNII:3NXW29V3WO) HYPROMELLOSE 2910 (3 MPA.S)4 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    POTASSIUM CHLORIDE (UNII: 660YQ98I10)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    WATER (UNII: 059QF0KO0R)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-930-1515 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34903/29/2011
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK
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