Trauma Cream description, usages, side effects, indications, overdosage, supplying and lots more!

Trauma Cream

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Trauma Cream

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

INDICATIONS & USAGE SECTION

Trauma Cream: Formulated for symptoms associated with injury, trauma or surgery such as pain, stiffness, swelling, bruising and inflammation.

DOSAGE & ADMINISTRATION SECTION

Directions: EXTERNAL USE ONLY. Ages 2 and up, apply a thin coating up to four times daily to affected area. Repeat as needed or as directed by your healthcare professional. Under age 2, consult a licensed healthcare professional. Avoid eye contact; if eye contact occurs, rinse with water for at least 15 minutes. If allergic response or irritation occurs or persists, discontinue use and consult a licensed healthcare professional.

OTC - ACTIVE INGREDIENT SECTION

Hepar sulph. calc. 10x, Hypericum 10x, Phosphorus 10x, Aconitum nap. 8x, Arnica 8x, Belladonna 8x, Bellis 8x, Calendula 8x, Colchicum 8x, Ledum 8x, Millefolium 8x, Rhus toxicodendron 8x, Apis mel. 3x, Arnica 3x, Calendula 3x, Chamomilla 3x, Echinacea 3x, Hamamelis 3x, Hydrastis 3x, Hypericum 3x, Ruta 3x, Symphytum 3x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with injury, trauma or surgery such as pain, stiffness, swelling, bruising and inflammation.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water, Pomace Olive Oil, El Deodorized Cocoa Butter, Beeswax (organic), Jojoba Esters, Soy Lecithin (organic), USP Glycerin, natural (organic, vegetable), USP Gluten-free, non-GMO Cane Alcohol (organic), Grapefruit Seed Extract, Plant preservatives (natural), Gluten-free, non-GMO Xanthan Gum.

OTC - QUESTIONS SECTION

www.newtonlabs.net  Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256

WARNINGS SECTION

Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

PACKAGE LABEL

Trauma Cream

Hepar sulph. calc., Hypericum, Phosphorus, Aconitum nap., Arnica, Belladonna, Bellis, Calendula, Colchicum, Ledum, Millefolium, Rhus toxicodendron, Apis mel., Chamomilla, Echinacea, Hamamelis, Hydrastis, Ruta, Symphytum CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2001
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
CALCIUM SULFIDE CALCIUM CATION 10 [hp_X]
Hypericum Perforatum HYPERICUM PERFORATUM 10 [hp_X]
PHOSPHORUS PHOSPHORUS 10 [hp_X]
ACONITUM NAPELLUS ACONITUM NAPELLUS 8 [hp_X]
ARNICA MONTANA ARNICA MONTANA 8 [hp_X]
ATROPA BELLADONNA ATROPA BELLADONNA 8 [hp_X]
BELLIS PERENNIS Bellis Perennis 8 [hp_X]
CALENDULA OFFICINALIS FLOWERING TOP CALENDULA OFFICINALIS FLOWERING TOP 8 [hp_X]
COLCHICUM AUTUMNALE BULB COLCHICUM AUTUMNALE BULB 8 [hp_X]
LEDUM PALUSTRE TWIG LEDUM PALUSTRE TWIG 8 [hp_X]
ACHILLEA MILLEFOLIUM 8 [hp_X]
TOXICODENDRON PUBESCENS LEAF TOXICODENDRON PUBESCENS LEAF 8 [hp_X]
APIS MELLIFERA APIS MELLIFERA 3 [hp_X]
Matricaria Recutita MATRICARIA RECUTITA 3 [hp_X]
ECHINACEA, UNSPECIFIED Echinacea, Unspecified 3 [hp_X]
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK 3 [hp_X]
GOLDENSEAL GOLDENSEAL 3 [hp_X]
RUTA GRAVEOLENS FLOWERING TOP RUTA GRAVEOLENS FLOWERING TOP 3 [hp_X]
COMFREY ROOT COMFREY ROOT 3 [hp_X]

Inactive Ingredients

Ingredient Name Strength
water
olive oil
COCOA BUTTER
ROYAL JELLY
Jojoba Oil
LECITHIN, SOYBEAN
GLYCERIN
ALCOHOL
CITRUS PARADISI SEED
LONICERA JAPONICA FLOWER
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2001-4 50 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-06-11


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