Label: CALENDULA OFFICINALIS- calendula officinalis flowering top liquid

  • NDC Code(s): 84292-270-01
  • Packager: Heavenly Herbals, Inc.
  • 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 May 4, 2024

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

  • Active Ingredients

    Calendula Officinalis Ø=1X
    Calendula Officinalis Flowering Top)

  • Purpose

    Promotes the healing of injured skin.

  • Dosage

    Unless otherwise prescribed, adults take 5-10 drops mixed with water, 2-3 times daily. For children under the age of 12, consult your physician.

  • Indications

    Promotes the healing of injured skin.

  • Warning and Precautions

    Contact physician if symptoms persist or worsen.

    if pregnant or breast-feeding, consult a health professional before use.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

    Store at room temperature.

    Protect from direct sun-light and heat.

    Particulate matter is common in the extract.

  • Children

    Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

  • Do Not Use

    Do not use this product if clear shrink band is missing.

  • Inactive Ingredients

    Alcohol 45% by volume.

  • Warning

    Contact physician if symptoms persist or worsen.

    if pregnant or breast-feeding, consult a health professional before use.

    In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

    Store at room temperature.

    Protect from direct sun-light and heat.

    Particulate matter is common in the extract.

  • Packaging Label

    Package Label

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFFICINALIS 
    calendula officinalis flowering top liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84292-270
    Route of AdministrationORAL
    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 60 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M) 45 mL  in 60 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84292-270-0160 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/23/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/23/2021
    Labeler - Heavenly Herbals, Inc. (105609629)
    Registrant - Heavenly Herbals, Inc. (105609629)
    Establishment
    NameAddressID/FEIBusiness Operations
    Heavenly Herbals, Inc.105609629manufacture(84292-270)