Trauma Cream

Trauma Cream
SPL v1
SPL
SPL Set ID 64a12947-c8c6-ff96-6816-ad0bfdbda054
Route
TOPICAL
Published
Effective Date 2013-08-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Calcium Sulfide (10 [hp_X]) Hypericum Perforatum (8 [hp_X]) Phosphorus (3 [hp_X]) Aconitum Napellus Arnica Montana Atropa Belladonna Bellis Perennis Calendula Officinalis Flowering Top Colchicum Autumnale Bulb Ledum Palustre Twig Achillea Millefolium Toxicodendron Pubescens Leaf Apis Mellifera Matricaria Recutita Echinacea, Unspecified Hamamelis Virginiana Root Bark/stem Bark Goldenseal Ruta Graveolens Flowering Top Comfrey Root
Inactive Ingredients
Water Olive Oil Cocoa Butter Royal Jelly Jojoba Oil Lecithin, Soybean Glycerin Alcohol Citrus Paradisi Seed Lonicera Japonica Flower Xanthan Gum

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2013-06-11

Description

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

Purpose

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


Medication Information

Purpose

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

Description

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

Package Label

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 Purpose Section

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

Otc Questions Section

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

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.

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 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


Structured Label Content

Package Label (PACKAGE LABEL)

Warnings Section (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 Purpose Section (OTC - PURPOSE SECTION)

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

Otc Questions Section (OTC - QUESTIONS SECTION)

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

Inactive Ingredient Section (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.

Indications & Usage Section (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 (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 (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 Pregnancy Or Breast Feeding Section (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 (OTC - KEEP OUT OF REACH OF CHILDREN SECTION)

Keep out of reach of children


Advanced Ingredient Data


Raw Label Data

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