FIRST DEGREE- calendula officinalis, echinacea angustifolia, cantharis vesicatoria tincture 
Welmedix LLC

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.

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First°Degree® Burn Cream

Active ingredients

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

wound healing, superficial burns and scalds

burns, scalds, rawness, burning pain

itching, burning, irritation from insect bites

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.

Warnings

For external use only

Do not use

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

do not get into eyes

Stop use and ask a doctor if

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

If pregnant or breast feeding

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

store at 15-30°C (59-86°F)

Inactive ingredients

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?

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

Principal Display Panel - First°Degree® Therapeutic Burn Cream

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

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

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

FIRST DEGREE 
calendula officinalis, echinacea angustifolia, cantharis vesicatoria tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24330-110
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 TOP1 [hp_Q]  in 0.1 g
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8) (ECHINACEA ANGUSTIFOLIA - UNII:VB06AV5US8) ECHINACEA ANGUSTIFOLIA1 [hp_Q]  in 0.1 g
LYTTA VESICATORIA (UNII: 3Q034RO3BT) (LYTTA VESICATORIA - UNII:3Q034RO3BT) LYTTA VESICATORIA3 [hp_X]  in 0.1 g
Inactive Ingredients
Ingredient NameStrength
SHEA BUTTER (UNII: K49155WL9Y)  
HYDROGENATED POLYDECENE (550 MW) (UNII: U333RI6EB7)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
LANOLIN (UNII: 7EV65EAW6H)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
TRIDECETH-10 (UNII: G624N6MSBA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:24330-110-211 in 1 CARTON01/01/2007
121 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:24330-110-141 in 1 CARTON05/01/2014
214 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:24330-110-221 in 1 CARTON03/01/2015
321 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved homeopathic01/01/2007
Labeler - Welmedix LLC (830387812)
Establishment
NameAddressID/FEIBusiness Operations
Denison Pharmaceuticals, LLC001207208MANUFACTURE(24330-110)

Revised: 8/2015
Document Id: 778699fa-4226-4ebb-8c47-cde4725e4ddb
Set id: e10bcfb8-079f-4033-a805-35d03c7ebd64
Version: 2
Effective Time: 20150812
 
Welmedix LLC