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 
Newton Laboratories, Inc.

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.

----------

Trauma Cream

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

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 TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Calcium Sulfide (UNII: 1MBW07J51Q) (Calcium Sulfide - UNII:1MBW07J51Q) Calcium Sulfide10 [hp_X]  in 1 g
Hypericum Perforatum (UNII: XK4IUX8MNB) (Hypericum Perforatum - UNII:XK4IUX8MNB) Hypericum Perforatum10 [hp_X]  in 1 g
Phosphorus (UNII: 27YLU75U4W) (Phosphorus - UNII:27YLU75U4W) Phosphorus10 [hp_X]  in 1 g
Aconitum Napellus (UNII: U0NQ8555JD) (Aconitum Napellus - UNII:U0NQ8555JD) Aconitum Napellus8 [hp_X]  in 1 g
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana8 [hp_X]  in 1 g
Atropa Belladonna (UNII: WQZ3G9PF0H) (Atropa Belladonna - UNII:WQZ3G9PF0H) Atropa Belladonna8 [hp_X]  in 1 g
Bellis Perennis (UNII: 2HU33I03UY) (Bellis Perennis - UNII:2HU33I03UY) Bellis Perennis8 [hp_X]  in 1 g
Calendula Officinalis Flowering Top (UNII: 18E7415PXQ) (Calendula Officinalis Flowering Top - UNII:18E7415PXQ) Calendula Officinalis Flowering Top8 [hp_X]  in 1 g
Colchicum Autumnale Bulb (UNII: 993QHL78E6) (Colchicum Autumnale Bulb - UNII:993QHL78E6) Colchicum Autumnale Bulb8 [hp_X]  in 1 g
Ledum Palustre Twig (UNII: 877L01IZ0P) (Ledum Palustre Twig - UNII:877L01IZ0P) Ledum Palustre Twig8 [hp_X]  in 1 g
Achillea Millefolium (UNII: 2FXJ6SW4PK) (Achillea Millefolium - UNII:2FXJ6SW4PK) Achillea Millefolium8 [hp_X]  in 1 g
Toxicodendron Pubescens Leaf (UNII: 6IO182RP7A) (Toxicodendron Pubescens Leaf - UNII:6IO182RP7A) Toxicodendron Pubescens Leaf8 [hp_X]  in 1 g
Apis Mellifera (UNII: 7S82P3R43Z) (Apis Mellifera - UNII:7S82P3R43Z) Apis Mellifera3 [hp_X]  in 1 g
Matricaria Recutita (UNII: G0R4UBI2ZZ) (Matricaria Recutita - UNII:G0R4UBI2ZZ) Matricaria Recutita3 [hp_X]  in 1 g
Echinacea, Unspecified (UNII: 4N9P6CC1DX) (Echinacea, Unspecified - UNII:4N9P6CC1DX) Echinacea, Unspecified3 [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 Bark3 [hp_X]  in 1 g
Goldenseal (UNII: ZW3Z11D0JV) (Goldenseal - UNII:ZW3Z11D0JV) Goldenseal3 [hp_X]  in 1 g
Ruta Graveolens Flowering Top (UNII: N94C2U587S) (Ruta Graveolens Flowering Top - UNII:N94C2U587S) Ruta Graveolens Flowering Top3 [hp_X]  in 1 g
Comfrey Root (UNII: M9VVZ08EKQ) (Comfrey Root - UNII:M9VVZ08EKQ) Comfrey Root3 [hp_X]  in 1 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55714-2001-450 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic06/11/2013
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2001)

Revised: 8/2013
Document Id: 9146c189-b164-3d6e-5e36-60e30677db72
Set id: 64a12947-c8c6-ff96-6816-ad0bfdbda054
Version: 1
Effective Time: 20130801
 
Newton Laboratories, Inc.