OCULINUM (EYE BALL) GRANULE [SEROYAL USA]

OCULINUM (EYE BALL) GRANULE [SEROYAL USA]
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NDC 62106-7105-4
Set ID 7b5c84a4-44a3-5a74-e053-2a91aa0ab2f4
Category HUMAN OTC DRUG LABEL
Packager Seroyal USA
Generic Name
Product Class
Product Number
Application Number
  • ACTIVE INGREDIENT

    OCULINUM 4CH

  • PURPOSE

    Indications

    Helps to support general eye health

  • WARNINGS

    WARNING: If pregnant or breastfeeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breastfeeding, ask a health professional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

    In case of overdose, get medical help or contact a Poison Control Center right away.

  • OTHER SAFETY INFORMATION

    Do not use if label perforation is broken

  • INACTIVE INGREDIENT

    INACTIVE INGREDIENTS: Lactose, sucrose

  • DOSAGE & ADMINISTRATION

    DIRECTIONS: Adults: Take five granules three times daily or as recommended by your healthcare practitioner. Children: Take three granules and follow adult directions.

  • INDICATIONS & USAGE

    Indications

    Helps to support general eye health

    DIRECTIONS: Adults: Take five granules three times daily or as recommended by your healthcare practitioner. Children: Take three granules and follow adult directions.

  • PRINCIPAL DISPLAY PANEL

    62106-7105

    Homeopathic Remedy

    NDC 62106-7105-4

    OCULINUM

    Eye ball

    140 granules

    Indications

    Helps to support general eye health

  • INGREDIENTS AND APPEARANCE
    OCULINUM 
    eye ball granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-7105
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ORYCTOLAGUS CUNICULUS EYE (UNII: NR12E54OPH) (ORYCTOLAGUS CUNICULUS EYE - UNII:NR12E54OPH) ORYCTOLAGUS CUNICULUS EYE4 [hp_C]
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
    SUCROSE (UNII: C151H8M554)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-7105-410 in 1 CARTON11/23/2018
    1140 in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic11/23/2018
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN’UP401010287manufacture(62106-7105)

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