Label: FIRST DEGREE- calendula officinalis, echinacea angustifolia, cantharis vesicatoria tincture

  • NDC Code(s): 24330-110-14, 24330-110-21, 24330-110-22
  • Packager: Welmedix LLC
  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated August 12, 2015

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  • 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

  • INGREDIENTS AND APPEARANCE
    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)
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