FDA.reportPublic FDA data

REMEDI Health Solutions

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

Label at a glance#

ProductREMEDI Health Solutions BURN RELIEF
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, CAPSICUM ANNUUM WHOLE, LYTTA VESICATORIA, URTICA URENS WHOLE
Label structure9 sections

Indications and uses

For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!

Dosage and administration

Apply to burned area. Spray topically or orally under tongue, every 5 minutes, 3 times in a row. Repeat every 20 minutes, 3 times in a row, then use as needed for up to 7 days. Pain relief and speed of healing should be obvious. Seek professional help if not resolving in a timely manner.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

CALENDULA OFFICINALIS 3x, 6c, 30c, 200c 
CAPSICUM ANNUUM 30c 
CANTHARIS VESICATORIA 30c
UTRICA URENS 30c

Purpose

OTC - PURPOSE SECTION

CALENDULA OFFICINALIS 3x, 6c, 30c, 200c .........Speed heals, reduces scarring, burning pain, redness,
                                                                                   blistering, peeling, urticaria, blotches
CAPSICUM ANNUUM 30c ....................................Burning pain, Redness
CANTHARIS VESICATORIA 30c ............................Blistering, peeling
UTRICA URENS 30c.............................................Urticaria, blotches

USES

INDICATIONS & USAGE SECTION

For pain relief, and accelerated healing of burns. Diminishes blistering. Great for Kids!

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 interactions.

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 burned area. Spray topically or orally under tongue, every 5 minutes, 3 times in a row. Repeat every 20 minutes, 3 times in a row, then use as needed for up to 7 days. Pain relief and speed of healing should be obvious. Seek professional help if not resolving in a timely manner.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua, Deionized Water, Glycerin, Potassium Sorbate, Sodium Benzoate

Questions/Comments? Side Effects?

OTC - QUESTIONS SECTION

TOLL FREE: Call 855 - 777 - 5875

SPL UNCLASSIFIED SECTION

Authentic Time-Tested Health Products

Relief of pain & blistering

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

SUGAR FREE
DAIRY FREE
SOY FREE
GLUTEN FREE
NON-GMO

Customers love this product!

SATISFACTION GUARANTEED

TAKE ME HOME!

Urgent Care! Great for Kitchens and First Aid!

ANTIBIOTIC FREE!

No known drug interactions

HIGH POTENCY
FASTER ACTING

100% Natural • 100% Drug Free
Fast Acting • Zero Side Effects
Safe for All Ages

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# 5998530532

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BurnrlfBurnrlf

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59985-305-322024-12-03C16284748780-1f386c64a-0a6b-0266-e053-dadaa90a7c1aREMEDI Health Solutions-BURN RELIEF
59985-305-322023-01-30C16284748780-1f386c64a-0a6b-0266-e053-dadaa90a7c1aREMEDI Health Solutions-BURN RELIEF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-305REMEDI HEALTH SOLUTIONS BURN RELIEF (CALENDULA OFFICINALIS, CAPSICUM ANNUUM, CANTHARIS VESICATORIA, UTRICA URENS) SPRAY [CHC MONTANA]4Legacy NDC20241205_331f9562-c4df-48fd-a512-d016570b6da2.zip

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59985-30559985-305-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAPSICUM ANNUUM WHOLE7FKZ3QQQ1FACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
URTICA URENS WHOLEIHN2NQ5OF9ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
SODIUM BENZOATEOJ245FE5EUIACT

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
9a05c6f8-7147-47bc-8043-e9c960d217a9331f9562-c4df-48fd-a512-d016570b6da22025-05-30WarningsExact identifier
spl set id: 331f9562-c4df-48fd-a512-d016570b6da2

Reported adverse events (FAERS/openFDA)#

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