Label: ARNICA CREAM- arnica montana cream
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Contains inactivated NDC Code(s)
NDC Code(s): 55714-2005-4 - 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.
- Download DRUG LABEL INFO: PDF XML
- 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.
- OTC - ACTIVE INGREDIENT SECTION
- 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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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
ARNICA CREAM
arnica montana creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55714-2005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW) Arnica Montana 60 [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:55714-2005-4 50 g in 1 BOTTLE, PUMP Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 08/01/2013 Labeler - Newton Laboratories, Inc. (788793610) Registrant - Newton Laboratories, Inc. (788793610) Establishment Name Address ID/FEI Business Operations Newton Laboratories, Inc. 788793610 MANUFACTURE(55714-2005)
