Label: REMEDI HEALTH SOLUTIONS CALENDULA CREAM- calendula officinalis cream

  • 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 January 6, 2021

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  • Drug Facts

  • HPUS Active Ingredients

    CALENDULA OFFICINALIS 3x, 6c, 30c, 200c

  • Purpose

    Speed heals, minimizes scarring

  • Uses

    Speed healing of wounds, sores, acne sores and lips. Reduces scarring.

  • Warnings

    Do not use if seal is broken or missing.

    As with any drug, ask a doctor before use if pregnant or breastfeeding. This formula is highly diluted homeopathic and is generally safe for all

    ages. Call your provider if symptoms worsen after 7 days. Homeopathic remedies have no known drug interaction.

    Keep this and all medication out of the reach of children. In case of accidental overdose contact a medical professional or Poison Control Center

    immediately. The active homeopathic ingredients are diluted beyond 1 part per million.

  • Directions

    Apply to sore or irritated area including skin, mouth, lips, genitals. Apply 3x's daily. Reduces scarring of sores. May be used additionally for

    comfort up to 7 days. May be applied to the wrist for internal healing benefits.

  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Deionized Water, Ethylhexyl Palmitate, Glycerin, Glyceryl Stearate, Glycol Stearate, Isostearyl

    Palmitate, Olea Europaea (Olive) Oil, Phenoxyethanol, Tocopheryl Acetate (Vitamin E), Zemea Propanediol

  • SPL UNCLASSIFIED SECTION

    Authentic Time-Tested Health Products

    Speed heals lips, wounds & sores

    Reduces scarring

    Homeopathic remedies have been effective and safe for over 200 years.

    SUGAR FREE • DAIRY FREE

    SOY FREE • GLUTEN FREE

    NON-GMO

    HIGH POTENCY

    FASTER ACTING

    100% Natural • 100% Drug Free

    Fast Acting • Zero Side Effects

    Safe for All Ages

    Customers love this product!

    HEALING POWER!

    Diminishes Pain

    Safe for face & lips

    Internal & External

    These statements are based upon traditional homeopathic principles. They have not been reviewed by the Food and Drug Administration.

    HOMEOPATHELLENSTURBO®

    PO Box 6 • Stevensville, MT 59870

    Since 1993

    Toll Free (855) 777-5875

    RemediHealthSolutions.com

    Manufactured by: PURE SOURCE LLC
    9750 NW17th St., Miami, FL 33172

    NDC# 5998510512

  • Packaging

    Calendula Cream

  • INGREDIENTS AND APPEARANCE
    REMEDI HEALTH SOLUTIONS  CALENDULA CREAM
    calendula officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59985-105
    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 TOP30 [hp_C]  in 28 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    ISOSTEARYL PALMITATE (UNII: 9EHU0R7ER1)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59985-105-121 in 1 BOX01/01/2019
    128 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/2019
    Labeler - Chc Montana (101745243)
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