ARNICA CREAM- arnica montana cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Arnica Montana (UNII: O80TY208ZW) (Arnica Montana - UNII:O80TY208ZW)

Available from:

Newton Laboratories, Inc.

INN (International Name):

Arnica Montana

Composition:

Arnica Montana 60 [hp_X] in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

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

Authorization status:

unapproved homeopathic

Summary of Product characteristics

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