Label: CALENDULA CREAM- calendula officinalis cream
ARNICA CREAM- arnica montana cream

  • NDC Code(s): 62106-1177-0, 62106-1180-0
  • Packager: Seroyal USA
  • 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 April 12, 2022

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  • ACTIVE INGREDIENT

    Active ingredients
    Calendula officinalis (Marigold) Aerial Parts MT 5.0%

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with minor cuts and burns

  • WARNINGS

    Warnings
    For external use only.
    Stop use and ask a doctor if symptoms persist or worsen.
    If pregnant or breastfeeding, 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetostearyl alcohol, glycerin, purified water, rose oil

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if inner seal is missing or broken.
    Store in a cool, dry place.

    Contents may not fill package in order to
    accommodate required labeling. Please
    rely on stated quantity

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Apply a small amount on the affected area two to three times daily, or as
    recommended by your healthcare practitioner.
    Children: Use under the direction of your healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptoms associated with minor cuts and burns

    Directions
    Adults: Apply a small amount on the affected area two to three times daily, or as
    recommended by your healthcare practitioner.
    Children: Use under the direction of your healthcare practitioner.

  • ACTIVE INGREDIENT

    Active ingredients
    This preparation contains:
    Arnica montana (Mountain arnica)
    Aerial Parts MT 5.0%
    Calendula officinalis (Marigold)
    Aerial Parts MT 2.0%

  • PURPOSE

    Uses
    For the temporary relief of symptoms associated with

    minor sprains and bruises.

  • WARNINGS

    Warnings
    For external use only.
    Do not use
    on irritated skin
    if excessive irritation develops
    When using this product, avoid getting
    into eyes or mucous membranes.
    Stop use and ask a doctor if symptoms
    persist or worsen.
    If pregnant or breastfeeding, 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.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • OVERDOSAGE

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

  • INACTIVE INGREDIENT

    Inactive ingredients
    Cetostearyl alcohol, glycerin, purified water

  • OTHER SAFETY INFORMATION

    Other information
    Do not use if inner seal is missing or
    broken.
    Store in a cool, dry place.

  • DOSAGE & ADMINISTRATION

    Directions
    Adults: Apply a small amount on the affected
    area two to three times daily, or as
    recommended by your healthcare practitioner.
    Children: Use under the direction of your
    healthcare practitioner.

  • INDICATIONS & USAGE

    Uses
    For the temporary relief of symptoms associated with minor sprains and bruises.

    Directions
    Adults: Apply a small amount on the affected
    area two to three times daily, or as
    recommended by your healthcare practitioner.
    Children: Use under the direction of your
    healthcare practitioner.

  • PRINCIPAL DISPLAY PANEL

    62106-1177-0

    NDC 62106-1177-0

    UNDA topicals

    CALENDULA CREAM

    Homeopathic Preparation

    For the temporary relief of symptoms
    associated with minor cuts and burns.

    Net Weight 1.4 oz (40 g)

  • PRINCIPAL DISPLAY PANEL

    NDC 62106-1180-0

    UNDA topicals

    ARNICA CREAM

    Arnica Cream

    Homeopathic Preparation

    For the temporary relief of symptoms associated
    with minor sprains and bruises.

    Net Weight 1.4 oz. (40 g)

  • INGREDIENTS AND APPEARANCE
    CALENDULA CREAM 
    calendula officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1177
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    WATER (UNII: 059QF0KO0R)  
    ROSE OIL (UNII: WUB68Y35M7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1177-01 in 1 CARTON01/20/2015
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2015
    ARNICA CREAM 
    arnica montana cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62106-1180
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA1 [hp_X]  in 40 g
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 40 g
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62106-1180-01 in 1 CARTON01/20/2015
    140 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/20/2015
    Labeler - Seroyal USA (018361118)
    Establishment
    NameAddressID/FEIBusiness Operations
    SAN'UP401010287manufacture(62106-1177, 62106-1180)
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