First°Degree ® Burn Cream

Manufacturer
Welmedix LLC | Denison Pharmaceuticals, LLC
Effective date
2015-08-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:06:49

Label at a glance#

ProductFirst Degree
Active ingredientCALENDULA OFFICINALIS FLOWERING TOP, ECHINACEA ANGUSTIFOLIA, LYTTA VESICATORIA
Label structure16 sections

Indications and uses

Temporarily relieves symptoms such as minor skin pain, rawness and itching due to: • minor burns • insect bites • minor scrapes • scalds Product Uses are based on the Homeopathic Materia Medica, and have not been evaluated by the Food and Drug Administration.

Dosage and administration

• for best results, apply immediately to affected area • adults and children 2 years of age and older: apply to affected area 2-3 times a day, as needed, or as directed by your doctor • children under 2 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Calendula officinalis TINC HPUS

Cantharis vesicatoria 3X HPUS

Echinacea angustifolia TINC HPUS

The letters ‘HPUS’ indicate that the active ingredients are officially monographed in the Homeopathic Pharmacopoeia of the United States. TINC and 3X are homeopathic dilutions: see www.firstdegree.com for details.

Purposes

OTC - PURPOSE SECTION

wound healing, superficial burns and scalds

burns, scalds, rawness, burning pain

itching, burning, irritation from insect bites

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves symptoms such as minor skin pain, rawness and itching due to:

  • minor burns
  • insect bites
  • minor scrapes
  • scalds

Product Uses are based on the Homeopathic Materia Medica, and have not been evaluated by the Food and Drug Administration.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you have an allergy or hypersensitivity to any ingredients or if you have had a prior reaction to this product
  • over large areas of the body
  • on deep or puncture wounds
  • on animal bites
  • on serious burns, cuts or scrapes

When using this product

OTC - WHEN USING SECTION

do not get into eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

If pregnant or breast feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for best results, apply immediately to affected area
  • adults and children 2 years of age and older: apply to affected area 2-3 times a day, as needed, or as directed by your doctor
  • children under 2 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

store at 15-30°C (59-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

butyrospermum parkii (shea butter), C18-22 hydroxyalkyl hydroxypropyl guar, hydrogenated polydecene, isopropyl myristate, lanolin, methylparaben, propylparaben, purified water, sodium polyacryloyldimethyl taurate, trideceth-10

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-565-2876 Monday through Friday, 9am-5pm

Principal Display Panel - First°Degree® Therapeutic Burn Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW

THERAPEUTIC
BURN
CREAM

First°Degree®

NDC 24330-0110-21

  • Soothes the pain & cools the burn
  • Acts as an antiseptic for burns
  • Helps reduce the appearance of scars

Homeopathic

Burns Happen. Be Prepared.™

NET WT. 3/4 OZ (21g)

Carton Label - First°Degree® Therapeutic Burn Cream
Carton Label - First°Degree® Therapeutic Burn Cream

Principal Display Panel - First°Degree® Burn Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BURN
CREAM

First°Degree®

  • Helps reduce the
    appearance of scars
  • Protects against infection
  • Soothes the pain
    & cools the burn

NET WT 1/2 oz (14 g)

1 TUBE

Homeopathic

Carton Label - First°Degree® Burn Cream
Carton Label - First°Degree® Burn Cream

Principal Display Panel – First°Degree® Multi-Symptom Burn Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

INSTANTLY SOOTHING!

96% NATURAL

First°Degree®

MULTI-SYMPTOM
BURN CREAM

SOOTHES THE PAIN
& COOLS THE BURN

HELPS HEAL
MINOR BURNS

HELPS REDUCE
THE APPEARANCE
OF SCARS

Net Wt 3/4 oz (21g)

1 TUBE

HOMEOPATHIC

Carton Label - First°Degree® Multi-Symptom Burn Cream
Carton Label - First°Degree® Multi-Symptom Burn Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
24330-110-14First Degree14 g in 1 TUBETINCTURE142
24330-110-14First Degree1 in 1 CARTONTINCTURE12
24330-110-21First Degree21 g in 1 TUBETINCTURE212
24330-110-21First Degree1 in 1 CARTONTINCTURE12
24330-110-22First Degree21 g in 1 TUBETINCTURE212
24330-110-22First Degree1 in 1 CARTONTINCTURE12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
24330-110FIRST DEGREE (CALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIA) TINCTURE [WELMEDIX LLC]2Current NDC, Legacy NDC, 6 package rows20150814_e10bcfb8-079f-4033-a805-35d03c7ebd64.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CALENDULA OFFICINALIS FLOWERING TOPACTIVE INGREDIENT18E7415PXQ2
ECHINACEA ANGUSTIFOLIAACTIVE INGREDIENTVB06AV5US82
LYTTA VESICATORIAACTIVE INGREDIENT3Q034RO3BT2
CALENDULA OFFICINALIS FLOWERING TOPACTIVE MOIETY18E7415PXQ2
ECHINACEA ANGUSTIFOLIAACTIVE MOIETYVB06AV5US82
LYTTA VESICATORIAACTIVE MOIETY3Q034RO3BT2
HYDROGENATED POLYDECENE (550 MW)INACTIVE INGREDIENTU333RI6EB72
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJS2
LANOLININACTIVE INGREDIENT7EV65EAW6H2
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T2
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH2
SHEA BUTTERINACTIVE INGREDIENTK49155WL9Y2
TRIDECETH-10INACTIVE INGREDIENTG624N6MSBA2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
24330-11024330-110-21, 24330-110-14, 24330-110-22

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYLPARABENMETHYLPARABENA2I8C7HI9TAEROSOL, FOAM / TOPICAL0.16 %w/wExact identifier — unii+route
56 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSPRAY / TOPICAL0.2 %w/wExact identifier — unii+route
56 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route
40 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route
40 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii+route
56 equally ranked IID candidates
TRIDECETH-10TRIDECETH-10G624N6MSBASOLUTION / TOPICAL4 %w/wExact identifier — unii+route
4 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLOTION / TOPICAL140 mgExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / TOPICAL3000 mgExact identifier — unii+route
56 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TLOTION / TOPICAL351 mgExact identifier — unii+route
56 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSSYSTEM / TOPICAL7 mgExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TJELLY / TOPICAL420 mgExact identifier — unii+route
56 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii+route
52 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSLOTION / TOPICAL50 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHGEL / TOPICAL4 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
56 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSOINTMENT / TOPICAL35 %w/wExact identifier — unii+route
40 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO, SUSPENSION / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii+route
20 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSHAMPOO / TOPICAL0.03 %w/wExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii+route
52 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HLOTION / TOPICAL1.5 %w/wExact identifier — unii+route
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii+route
56 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route
56 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHLIQUID / TOPICAL0.1 %w/wExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
52 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSGEL / TOPICAL29 mgExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHCREAM / TOPICAL6 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii+route
52 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii+route
40 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HSHAMPOO / TOPICAL2 %w/wExact identifier — unii+route
20 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HCREAM / TOPICAL10 mgExact identifier — unii+route
20 equally ranked IID candidates
ISOPROPYL MYRISTATEISOPROPYL MYRISTATE0RE8K4LNJSAEROSOL, SPRAY / TOPICAL6.89 %w/wExact identifier — unii+route
40 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHJELLY / TOPICAL180 mgExact identifier — unii+route
52 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii+route
56 equally ranked IID candidates
LANOLINLANOLIN7EV65EAW6HEMULSION / TOPICAL0.25 %w/wExact identifier — unii+route
20 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSHAMPOO / TOPICAL0.15 %w/wExact identifier — unii+route
56 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHAEROSOL, FOAM / TOPICAL0.04 %w/wExact identifier — unii+route
52 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TGEL / TOPICAL24 mgExact identifier — unii+route
56 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSPRAY / TOPICAL0.8 %w/wExact identifier — unii+route
52 equally ranked IID candidates

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
First DegreeCALENDULA OFFICINALIS, ECHINACEA ANGUSTIFOLIA, CANTHARIS VESICATORIAWelmedix LLCe10bcfb8-079f-4033-a805-35d03c7ebd642015-08-12WarningsExact identifier
ndc (package): 24330-110-22
ndc (package): 24330-110-21
ndc (package): 24330-110-14
ndc (product): 24330-110
ndc11 (package): 24330011014
ndc11 (package): 24330011021
ndc11 (package): 24330011022
spl id: 778699fa-4226-4ebb-8c47-cde4725e4ddb
spl set id: e10bcfb8-079f-4033-a805-35d03c7ebd64

Reported adverse events (FAERS/openFDA)#

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