FDA Label for Arnica Cream
View Indications, Usage & Precautions
Arnica Cream Product Label
The following document was submitted to the FDA by the labeler of this product Newton Laboratories, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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