Label: CALENDULA OFF gel

  • Category: HUMAN OTC DRUG LABEL

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 March 30, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    CALENDULA OFF GEL TINC HPUS

  • USES

    Minor cuts, scrapes, burns, skin irritation and diaper rash

  • INDICATIONS

    Condition listed above or as directed by the physician

  • DOSAGE & ADMINISTRATION SECTION

    Apply a thin layer of Gel to the affected area, repeat 3 times a day or as needed.

  • WARNINGS

    This product is to be used for self-limiting conditions

    If symptoms do not improve in 4 days, or worsen, discontinue use and seek assistance of health professional

    As with any drug, if you are preganant, or nursing a baby, seek professional advice before taking this product

    Keep this and all medication out of reach of children

    Do not use if capseal is broken or missing.
    Close the cap tightly after use.

  • INACTIVE INGREDIENTS

    ALOE VERA GEL

  • STORAGE

    Store in a cool dark place

  • QUESTIONS OR COMMENTS

    www.Rxhomeo.com | 1.888.2796642 | info@rxhomeo.com

    Rxhomeo, Inc 9415 Burnet Road, Suite 312, Austin, TX 78758

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    CALENDULA OFF 
    calendula off gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:15631-2310
    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 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:15631-2310-01 in 1 CONTAINER03/30/2016
    150 g in 1 CONTAINER; Type 0: Not a Combination Product
    2NDC:15631-2310-11 in 1 CONTAINER03/30/2016
    2100 g in 1 CONTAINER; Type 0: Not a Combination Product
    3NDC:15631-2310-21 in 1 CONTAINER03/30/2016
    3200 g in 1 CONTAINER; Type 0: Not a Combination Product
    4NDC:15631-2310-31 in 1 CONTAINER03/30/2016
    4500 g in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/30/2016
    Labeler - Rxhomeo Private Limited d.b.a. Rxhomeo, Inc (650833994)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rxhomeo Private Limited d.b.a. Rxhomeo, Inc650833994manufacture(15631-2310) , label(15631-2310)