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 20:47:49

Label at a glance#

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

Indications and uses

Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!

Dosage and administration

Apply to the burned area. Spray topically and/or under the tongue every 5 minutes 3 times in a row. Apply as needed for pain.

Label contents#

Full prescribing information#

HPUS Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

CALENDULA OFFICINALIS 3x, 6c, 30c .........Reduces scarring & pain
CAPSICUM ANNUUM 30c ........................ Reduces redness & heat
CANTHARIS VESICATORIA 30c ...... Reduces peeling, blistering

USES

INDICATIONS & USAGE SECTION

Use orally and or topically for scarring, pain, blistering. Reduces peeling. FAST RELIEF!

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 the burned area. Spray topically and/or under the tongue every 5 minutes 3 times in a row. Apply as needed for pain.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

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

Diminish peeling, stinging & 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

VACATION SAVER!

Relief for urgent pain & blistering.

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# 5998531532

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SunbrnSunbrn

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59985-315-322024-12-03C16284748780-1f386c649-b900-0266-e053-dadaa90a7c1aREMEDI Health Solutions-SUNBURN RELIEF
59985-315-322023-01-30C16284748780-1f386c649-b900-0266-e053-dadaa90a7c1aREMEDI Health Solutions-SUNBURN RELIEF

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59985-315REMEDI HEALTH SOLUTIONS SUNBURN RELIEF (CALENDULA OFFICINALIS, CAPSICUM ANNUUM, CANTHARIS VESICATORIA) SPRAY [CHC MONTANA]4Legacy NDC20241205_632bf52c-6ac9-4c27-bb73-a97c7e7a4b08.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59985-31559985-315-32

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALENDULA OFFICINALIS FLOWERING TOP18E7415PXQACTIB
CAPSICUM ANNUUM WHOLE7FKZ3QQQ1FACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
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
64e0f9f3-ed3a-436b-8bc2-ccd766a695d6632bf52c-6ac9-4c27-bb73-a97c7e7a4b082025-05-30WarningsExact identifier
spl set id: 632bf52c-6ac9-4c27-bb73-a97c7e7a4b08

Reported adverse events (FAERS/openFDA)#

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