FDA.reportPublic FDA data

REMEDI Health Solutions-CALENDULA Cream

Manufacturer
Chc Montana
Effective date
2024-11-06
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 20:47:50

Label at a glance#

ProductREMEDI Health Solutions CALENDULA Cream
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP
Label structure8 sections

Indications and uses

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

Dosage and administration

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.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Speed heals, minimizes scarring

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Calendula CreamCalendula Cream

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59985-105-122024-12-03C16284748780-1f386c649-ffab-0266-e053-dadaa90a7c1aREMEDI Health Solutions-CALENDULA Cream
59985-105-122023-01-30C16284748780-1f386c649-ffab-0266-e053-dadaa90a7c1aREMEDI Health Solutions-CALENDULA Cream

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-105REMEDI HEALTH SOLUTIONS CALENDULA CREAM (CALENDULA OFFICINALIS) CREAM [CHC MONTANA]4Legacy NDC20241205_85dbb272-e0ab-4a20-86e0-7e473d0e549d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59985-10559985-105-12

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ETHYLHEXYL PALMITATE2865993309IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
GLYCOL STEARATE0324G66D0EIACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
OLIVE OIL6UYK2W1W1EIACT
PHENOXYETHANOLHIE492ZZ3TIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPANEDIOL5965N8W85TIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d5c9d040-9979-4d38-a85a-9315fe8b48cc85dbb272-e0ab-4a20-86e0-7e473d0e549d2025-05-29WarningsExact identifier
spl set id: 85dbb272-e0ab-4a20-86e0-7e473d0e549d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.