ARNICA CREAM - arnica montana 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.

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Arnica Cream

INDICATIONS & USAGE SECTION

Arnica Cream: Formulated for symptoms associated with trauma, surgery, strains and sprains such as bruising, swelling, pain and stiffness.

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

Arnica 60x, Arnica 30x, Arnica 10x, Arnica 3x

OTC - PURPOSE SECTION

 Formulated for symptoms associated with trauma, surgery, strains and sprains such as bruising, swelling, pain and stiffness.

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.

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

ARNICA CREAM  
arnica montana cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55714-2005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana60 [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:55714-2005-450 g in 1 BOTTLE, PUMP
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic08/01/2013
Labeler - Newton Laboratories, Inc. (788793610)
Registrant - Newton Laboratories, Inc. (788793610)
Establishment
NameAddressID/FEIBusiness Operations
Newton Laboratories, Inc.788793610MANUFACTURE(55714-2005)

Revised: 8/2013
Document Id: 8beb84de-4842-4cac-9118-6d33fa64b1d9
Set id: 294fed87-9386-675b-5b2c-a37a63f2870b
Version: 1
Effective Time: 20130801
 
Newton Laboratories, Inc.