Arnica Cream description, usages, side effects, indications, overdosage, supplying and lots more!

Arnica Cream

Newton Laboratories, Inc.
Newton Laboratories, Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Arnica Cream

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Arnica Cream

Arnica montana CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:55714-2005
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ARNICA MONTANA ARNICA MONTANA 60 [hp_X]

Inactive Ingredients

Ingredient Name Strength
water
olive oil
COCOA BUTTER
ROYAL JELLY
Jojoba Oil
LECITHIN, SOYBEAN
GLYCERIN
ALCOHOL
CITRUS PARADISI SEED
LONICERA JAPONICA FLOWER
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:55714-2005-4 50 in 1 BOTTLE, PUMP

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2013-08-01


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