First°degree®

First°degree®
SPL v2
SPL
SPL Set ID e10bcfb8-079f-4033-a805-35d03c7ebd64
Route
TOPICAL
Published
Effective Date 2010-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calendula Officinalis Flowering Top (1 [hp_Q]) Echinacea Angustifolia (3 [hp_X]) Lytta Vesicatoria
Inactive Ingredients
Shea Butter Hydrogenated Polydecene (550 Mw) Isopropyl Myristate Lanolin Methylparaben Propylparaben Water Trideceth-10

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2007-01-01

Description

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.

Purpose

wound healing, superficial burns and scalds burns, scalds, rawness, burning pain itching, burning, irritation from insect bites


Medication Information

Purpose

wound healing, superficial burns and scalds burns, scalds, rawness, burning pain itching, burning, irritation from insect bites

Description

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.

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.

Purposes

wound healing, superficial burns and scalds

burns, scalds, rawness, burning pain

itching, burning, irritation from insect bites

Warnings

For external use only

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
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
Other Information

store at 15-30°C (59-86°F)

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.

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

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.

Principal Display Panel First°degree®

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
Principal Display Panel – First°degree®

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

Structured Label Content

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.

Purposes

wound healing, superficial burns and scalds

burns, scalds, rawness, burning pain

itching, burning, irritation from insect bites

Warnings

For external use only

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
Do Not Use (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
Other Information (Other information)

store at 15-30°C (59-86°F)

Active Ingredients (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.

Inactive Ingredients (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? (Questions or comments?)

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

When Using This Product (When using this product)

do not get into eyes

Stop Use and Ask A Doctor If (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 (If pregnant or breast feeding)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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

Principal Display Panel First°degree® (Principal Display Panel - First°Degree®)

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
Principal Display Panel – First°degree® (Principal Display Panel – First°Degree®)

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

Advanced Ingredient Data


Raw Label Data

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