Label: C-MORE GLYCERIN LUBRICANT EYE DROPS- glycerin 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 October 6, 2022

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

  • Drug Facts

  • Active ingredient

    Glycerin 1%

  • Purpose

    Lubricant

  • Use

    for use as a lubricant to prevent further irritation or to relieve dryness of the eye

  • Warnings

    For external use only

    Do not use if solution changes color or becomes cloudy

    When using this product
    • to avoid contamination, do not touch tip of container to any surface
    • replace cap after using

    Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the 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.

  • Directions

    • instill 1 or 2 drops in the affected eye(s) as needed
    • use the solution within one month after opening the container

  • Other information

    • store between 20 - 25°C (68 -77°F) in a cool, dry place
    • do not use if the seal on the bottle is broken or missing

  • Inactive ingredients

    benzyl alcohol, boric acid, citric acid, hypromellose, n-acetylcarnosine, potassium bicarbonate, sterile water

  • Questions?

    +1-800-814-7385

    You may also report serious side effects to this phone number.

    Mon-Fri 9:00 AM - 5:00 PM (PST)

  • SPL UNCLASSIFIED SECTION

    Sterile

    C-More Glycerin Lubricant Eye Drops is formulated to soothe irritated eyes and relieve dryness of the eye. This hydrating formula
    prevents further irritation and keeps the eyes lubricated.

    NOT FOR INJECTION

    Distributed by:
    Profound Nutrition Ltd.,
    C/O 2 Apex Business Centre,
    Boscombe Road, Dunstable,
    Bedfordshire, England LU54SB

    www.profound-nutrition.com

    Use before expiration date marked on the carton and bottle.

    PRODUCT OF INDIA

    Do not use if the seal on the bottle is broken or missing

  • Packaging

    Cmore-4

  • INGREDIENTS AND APPEARANCE
    C-MORE GLYCERIN LUBRICANT EYE DROPS 
    glycerin solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82974-001
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN13 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    BORIC ACID (UNII: R57ZHV85D4)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    N-ACETYLCARNOSINE (UNII: 0TPN86OQIF)  
    POTASSIUM BICARBONATE (UNII: HM5Z15LEBN)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82974-001-232 in 1 CARTON10/06/2022
    15 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34910/06/2022
    Labeler - PROFOUND NUTRITION LIMITED (771201696)