Arnica Cream

Manufacturer: Newton Laboratories, Inc.
Effective date: 2013-08-01
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:05:20

Label at a glance#

ProductArnica Cream

Active ingredientArnica Montana

Label structure10 sections

Contacts and useful links#

PhoneLabel contact1.800.448.7256

Websitewww.newtonlabs.net

www.newtonlabs.net

Label 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

OTC - 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.PRINCIPAL DISPLAY PANEL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
55714-2005-4	2020-01-31	C162847	48780-1	9d75b9cf-f1ee-f424-e053-dadaa90a57ce	Arnica Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55714-2005-4	Arnica Cream	50 g in 1 BOTTLE, PUMP	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55714-2005	ARNICA CREAM (ARNICA MONTANA) CREAM [NEWTON LABORATORIES, INC.]	1	Legacy NDC, 1 package rows	20131227_294fed87-9386-675b-5b2c-a37a63f2870b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Arnica Montana	ACTIVE INGREDIENT	O80TY208ZW	1
Arnica Montana	ACTIVE MOIETY	O80TY208ZW	1
Alcohol	INACTIVE INGREDIENT	3K9958V90M	1
Citrus Paradisi Seed	INACTIVE INGREDIENT	12F08874Y7	1
Cocoa Butter	INACTIVE INGREDIENT	512OYT1CRR	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
Jojoba Oil	INACTIVE INGREDIENT	724GKU717M	1
Lecithin, Soybean	INACTIVE INGREDIENT	1DI56QDM62	1
Lonicera Japonica Flower	INACTIVE INGREDIENT	4465L2WS4Y	1
Olive Oil	INACTIVE INGREDIENT	6UYK2W1W1E	1
Royal Jelly	INACTIVE INGREDIENT	L497I37F0C	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

Arnica Cream
Arnica montana
Water
Olive Oil
Cocoa Butter
Royal Jelly
Jojoba Oil
Lecithin, Soybean
Glycerin
Alcohol
Citrus Paradisi Seed
Lonicera Japonica Flower
Xanthan Gum

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
55714-2005	55714-2005-4

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Arnica Montana	O80TY208ZW	ACTIB
Water	059QF0KO0R	IACT
Olive Oil	6UYK2W1W1E	IACT
Cocoa Butter	512OYT1CRR	IACT
Royal Jelly	L497I37F0C	IACT
Jojoba Oil	724GKU717M	IACT
Lecithin, Soybean	1DI56QDM62	IACT
Glycerin	PDC6A3C0OX	IACT
Alcohol	3K9958V90M	IACT
Citrus Paradisi Seed	12F08874Y7	IACT
Lonicera Japonica Flower	4465L2WS4Y	IACT
Xanthan Gum	TTV12P4NEE	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 176 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRAMUSCULAR		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY, METERED / SUBLINGUAL		29 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CAPSULE / ORAL		882 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LIQUID / ORAL		3563 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TOPICAL		9971 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	MOUTHWASH / BUCCAL	100 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / TRANSDERMAL	49.37 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	TABLET / ORAL		8 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	35.75 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL, METERED / TOPICAL		541 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPONGE / TOPICAL	2 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / ORAL	210 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	POWDER, FOR SUSPENSION / ORAL		39 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	ENEMA / RECTAL		150 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	TABLET, DELAYED RELEASE / ORAL	NA		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SWAB / TOPICAL		2250 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION, CONCENTRATE / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET / ORAL		56 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION / INTRAVASCULAR	100 %v/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	INJECTION, SOLUTION / INTRAVENOUS		6405 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	TABLET / ORAL		42 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SUPPOSITORY / VAGINAL	227.9 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SHAMPOO / TOPICAL		714 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	DROPS / NASAL	10 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / NASAL	20 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	SOLUTION / ORAL	425 mg/1ml		Exact identifier — unii candidate 5 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / TRANSDERMAL		7360 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / OPHTHALMIC	6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	GEL / OPHTHALMIC	0.88 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Lecithin, Soybean	SOYBEAN LECITHIN	1DI56QDM62	TABLET, FILM COATED / ORAL	0.33 mg		Exact identifier — unii candidate 7 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SOLUTION / ORAL		84 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL / TOPICAL		561 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	GEL / DENTAL	1.8 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 59 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SYSTEM / TOPICAL		18144 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION / ORAL		360 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
Xanthan Gum	XANTHAN GUM	TTV12P4NEE	TABLET, FILM COATED / ORAL	0.08 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
Olive Oil	OLIVE OIL	6UYK2W1W1E	LOTION / TOPICAL		32468 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	AEROSOL, METERED / NASAL	70 mg		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SOLUTION / ORAL		6624 mg	Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	CONCENTRATE / BUCCAL	679 mg/1ml		Exact identifier — unii candidate 59 equally ranked IID candidates
Alcohol	ALCOHOL	3K9958V90M	SPRAY / NASAL		20 mg	Exact identifier — unii candidate 59 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
8beb84de-4842-4cac-9118-6d33fa64b1d9			294fed87-9386-675b-5b2c-a37a63f2870b	2013-08-01	Warnings	Exact identifier spl id: 8beb84de-4842-4cac-9118-6d33fa64b1d9 spl set id: 294fed87-9386-675b-5b2c-a37a63f2870b

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.