Label: PINK EYE- belladonna, euphrasia officinalis, hepar sulphuris solution/ drops

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated February 12, 2019

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Belladonna 6X†

    Euphrasia officinalis (Eyebright) 6X

    Hepar sulphuris 12X

  • Purpose

    dryness, redness, burning, sensation of grittiness

    watery discharge

    redness, stinging

  • Uses**

    According to homeopathic principles, the active ingredients in this product temporarily relieve minor eye symptoms:

    • excessive watery (clear) discharge

    • sensation of grittiness

    • redness and burning

  • Warnings

    • For external use only.

    • Children under 2 years of age should be seen by a physician.

    • According to homeopathic principles, symptoms may temporarily worsen before improving (Initial exacerbation of symptoms).

    • To avoid contamination, do not touch the tip of the bottle to any surface.

    • To avoid contamination use within 30 days of opening. Expiration date only refers to unopened bottle.

    • Replace cap tightly after every use.

    • Contact wearers: consult physician prior to using.

    If pregnant, trying to get pregnant or breast feeding,

    ask a health professional before use.

    Keep out of reach of children.

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

    Do not use:

    • if the solution changes color or becomes cloudy

    Stop use and ask a doctor if:

    • you experience eye pain or changes in vision

    • symptoms worsen or persist for more than 72 hours

    • you might have a serious underlying medical cause for an infection

  • Directions

    For adults and children ages 2 and over:

    • remove tamper-evident seal from neck of bottle

    • twist cap off bottle

    • DON’T squeeze bottle, squeeze plastic tip to release 2-3 drops into eye

    • apply as needed

    • replace cap after use

  • Other information

    Active ingredients are manufactured according to homeopathic principles.

  • Inactive ingredients

    Borate buffer, Purified water, Silver sulfate (as preservative), Sodium nitrate

  • PRINCIPAL DISPLAY PANEL

    Pink Eye
    Drops
    STERILE EYE DROPS
    10 ml (0.33 FL OZ)

    PRINCIPAL DISPLAY PANEL Pink Eye Drops STERILE EYE DROPS 10 ml (0.33 FL OZ)

  • INGREDIENTS AND APPEARANCE
    PINK EYE 
    belladonna, euphrasia officinalis, hepar sulphuris solution/ drops
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69842-901
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ATROPA BELLADONNA (UNII: WQZ3G9PF0H) (ATROPA BELLADONNA - UNII:WQZ3G9PF0H) ATROPA BELLADONNA6 [hp_X]  in 10 mL
    EUPHRASIA STRICTA (UNII: C9642I91WL) (EUPHRASIA STRICTA - UNII:C9642I91WL) EUPHRASIA STRICTA6 [hp_X]  in 10 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE12 [hp_X]  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SILVER SULFATE (UNII: 8QG6HV4ZPO)  
    SODIUM NITRATE (UNII: 8M4L3H2ZVZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69842-901-111 in 1 CARTON02/15/2019
    110 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/15/2019
    Labeler - CVS Pharmacy (062312574)
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