ARNICA GEL 15 ARNICA MONTANA 1X HPUS- arnica gel gel

Arnica Gel 15 by

Drug Labeling and Warnings

Arnica Gel 15 by is a Homeopathic medication manufactured, distributed, or labeled by VITAMEDICA, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT:

Arnica Montana 200C HPUS.**

**The letters 'HPUS' indicate that the component in this product is officially monographed in the Homeopathic Pharmacopoeia of the United States. This product has been manufactured at an FDA-regulated facility.

PURPOSE:

Arnica Montana - Disoloration from bruising; relieves join and muscle pain, soreness & stiffness; relieves swelling from *

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

USES:

*Temporarily relieves these symptoms:

Bruising  Swelling  Pain  Stiff  Muscle Soreness 

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

For extrenal use only. Avoid contract with eyes and mucous membranes.

Do not use on open wounds or broken skin

Stop use or consult a physician if

 A rash or irritation occurs

Symptoms persist for more than 7 days or worsen.

Keep this and all medications out of reach of children.

If sawllowed, seek medical attention or contact a Poison control center immediately.

KEEP OUT OF REACH OF CHILDREN:

If swallowed, seek medical attention or contact a Poison Control Center immediately.

DIRECTIONS:

Apply a thin layer of gel to target area. Reapply 3 times daily or as needed.

Other Information

Other Information

Do not use if tamper evident seal is broken.

Store at 68-77°F (20-25°C)

INACTIVE INGREDIENTS:

Water, Aloe Vera Leaf Juice Extract, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide, Ethanol

QUESTIONS:

Formulated and Distributed by

VitaMedica, Inc.

Tampa, FL 33624

©2024 VitaMedica, Inc.

www.vitamedica.com

888-367-8605

customerservice@vitamedica.com

Label

NDC: 80004-400-40

Pain Relief*

VitaMedica

Arnica Gel + 15

Extra Strength Pain Relief

INGREDIENTS AND APPEARANCE

ARNICA GEL 15  ARNICA MONTANA 1X HPUS
arnica gel gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 80004-400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB)	HYPERICUM PERFORATUM	1 [hp_X]  in 1 g
SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y)	SYMPHYTUM OFFICINALE WHOLE	6 [hp_X]  in 1 g
ARNICA MONTANA WHOLE (UNII: O80TY208ZW) (ARNICA MONTANA WHOLE - UNII:O80TY208ZW)	ARNICA MONTANA WHOLE	30 [hp_C]  in 1 g
RHUS TYPHINA WHOLE (UNII: Y465D8AABT) (RHUS TYPHINA WHOLE - UNII:Y465D8AABT)	RHUS TYPHINA WHOLE	30 [hp_X]  in 1 g
HAMAMELIS VIRGINIANA BARK (UNII: IH3063S9MY) (HAMAMELIS VIRGINIANA BARK - UNII:IH3063S9MY)	HAMAMELIS VIRGINIANA BARK	1 [hp_X]  in 1 g
CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ)	CALENDULA OFFICINALIS FLOWERING TOP	1 [hp_X]  in 1 g
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ) (ARNICA MONTANA FLOWER - UNII:OZ0E5Y15PZ)	ARNICA MONTANA FLOWER	1 [hp_X]  in 1 g
LEDUM PALUSTRE WHOLE (UNII: 1N8KG72C5M) (LEDUM PALUSTRE WHOLE - UNII:1N8KG72C5M)	LEDUM PALUSTRE WHOLE	12 [hp_X]  in 1 g
ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA) (ACHILLEA MILLEFOLIUM FLOWER - UNII:YQR8R0SQEA)	ACHILLEA MILLEFOLIUM FLOWER	12 [hp_X]  in 1 g
BELLADONNA LEAF (UNII: 6GZW20TIOI) (BELLADONNA LEAF - UNII:6GZW20TIOI)	BELLADONNA LEAF	30 [hp_X]  in 1 g
BELLIS PERENNIS FLOWER (UNII: 26I94X9A1K) (BELLIS PERENNIS FLOWER - UNII:26I94X9A1K)	BELLIS PERENNIS FLOWER	12 [hp_X]  in 1 g
RUTA GRAVEOLENS WHOLE (UNII: 181JI0338P) (RUTA GRAVEOLENS WHOLE - UNII:181JI0338P)	RUTA GRAVEOLENS WHOLE	30 [hp_X]  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM DISODIUM EDTA (UNII: 8U5D034955)
2-ETHYLHEXYL GLYCIDYL ETHER (UNII: LU1UZ98B89)
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
2-(ETHYLTHIO)ETHANOL (UNII: 6091RQ1378)
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF JUICE (UNII: RUE8E6T4NB)
BENZYL ALCOHOL (UNII: LKG8494WBH)

Product Characteristics
Color	white (Gel)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 80004-400-40	1 in 1 CARTON	03/01/2024
1		85 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		03/01/2024

Labeler - VITAMEDICA, INC. (119401422)