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
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2001-4 - Packager: Newton Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved homeopathic
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 1, 2013
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- INDICATIONS & USAGE SECTION
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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.
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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
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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.
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OTC - QUESTIONS SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012 Questions? 1.800.448.7256
- WARNINGS SECTION
- OTC - PREGNANCY OR BREAST FEEDING SECTION
- OTC - KEEP OUT OF REACH OF CHILDREN SECTION
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
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 creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide 10 [hp_X] in 1 g Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum 10 [hp_X] in 1 g Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus 10 [hp_X] in 1 g Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus 8 [hp_X] in 1 g Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 8 [hp_X] in 1 g Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna 8 [hp_X] in 1 g Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis 8 [hp_X] in 1 g Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top 8 [hp_X] in 1 g Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb 8 [hp_X] in 1 g Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig 8 [hp_X] in 1 g Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium 8 [hp_X] in 1 g Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf 8 [hp_X] in 1 g Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera 3 [hp_X] in 1 g Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita 3 [hp_X] in 1 g Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified 3 [hp_X] in 1 g Hamamelis Virginiana Root Bark/stem Bark (UNII: T7S323PKJS) (Hamamelis Virginiana Root Bark/stem Bark - UNII:T7S323PKJS) Hamamelis Virginiana Root Bark/stem Bark 3 [hp_X] in 1 g Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal 3 [hp_X] in 1 g Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top 3 [hp_X] in 1 g Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root 3 [hp_X] in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Olive Oil (UNII: 6UYK2W1W1E) Cocoa Butter (UNII: 512OYT1CRR) Royal Jelly (UNII: L497I37F0C) Jojoba Oil (UNII: 724GKU717M) Lecithin, Soybean (UNII: 1DI56QDM62) Glycerin (UNII: PDC6A3C0OX) Alcohol (UNII: 3K9958V90M) Citrus Paradisi Seed (UNII: 12F08874Y7) Lonicera Japonica Flower (UNII: 4465L2WS4Y) Xanthan Gum (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55714-2001-4 50 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 06/11/2013 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2001)
