Arnica Gel 15

Manufacturer
VITAMEDICA, INC.
Effective date
2024-03-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:38:15

Key Label Information#

Active Ingredients And Purpose

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

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

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.

Directions And Dosage

DIRECTIONS:

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

Other Label Information

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

Label Images#

Arnica Gel
Arnica Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS85 g in 1 TUBEGEL851
80004-400-40Arnica Gel 15Arnica Montana 1X HPUS1 in 1 CARTONGEL11

Products#

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80004-40080004-400-40

Ingredients#

Complete SPL Sections#

ACTIVE INGREDIENT:

OTC - ACTIVE INGREDIENT SECTION

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:

OTC - PURPOSE SECTION

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:

INDICATIONS & USAGE SECTION

*Temporarily relieves these symptoms: • Bruising • Swelling • Pain • Stiff • Muscle Soreness *Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

WARNINGS:

WARNINGS SECTION

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:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

Other Information

OTHER SAFETY INFORMATION

Other Information • Do not use if tamper evident seal is broken. • Store at 68-77°F (20-25°C)

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

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

QUESTIONS:

OTC - QUESTIONS SECTION

Formulated and Distributed by VitaMedica, Inc. Tampa, FL 33624 ©2024 VitaMedica, Inc. www.vitamedica.com 888-367-8605 customerservice@vitamedica.com

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 80004-400-40 Pain Relief* VitaMedica Arnica Gel + 15 Extra Strength Pain Relief

Source Document#

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