Advanced Arnica

Advanced Arnica
SPL v2
SPL
SPL Set ID 48c0b84f-13f0-4f63-bff8-7e600be51059
Route
ORAL
Published
Effective Date 2018-05-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X]) Arnica Montana Root
Inactive Ingredients
Water Carya Ovata Bark Citrus Bioflavonoids Lonicera Japonica Flower Polyepsilon-lysine (4000 Mw) Rebaudioside A

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2018-05-31

Description

Drug Facts ____________________________________________________________________________________________________________________ HPUS active ingredients: Arnica montana, Arnica montana, radix . Equal volumes of each ingredient in 6X, 30X, 6C, 30C, 1LM, 2LM, 3LM potencies.


Medication Information

Warnings and Precautions

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

Indications and Usage

Uses​ temporarily relieves symptoms due to injury or overexertion: bruises, muscle pain, inflammation, body aches, sprains, traumatic injury, redness and swelling, soreness after exercise, rheumatic pain.

Dosage and Administration

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12 : 2 sprays 3 times per day.
  • Children 2 mo-2 yr: 1 spray 3 times per day.
Description

Drug Facts ____________________________________________________________________________________________________________________ HPUS active ingredients: Arnica montana, Arnica montana, radix . Equal volumes of each ingredient in 6X, 30X, 6C, 30C, 1LM, 2LM, 3LM potencies.

Section 50565-1
  • Keep out of reach of children.
Section 51727-6

Inactive ingredients: Bio-Energetically Enhanced pure water, Carya ovata bak extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Section 51945-4

Section 55105-1

Uses temporarily relieves symptoms due to injury or overexertion:

  • bruises
  • muscle pain
  • inflammation
  • body aches
  • sprains
  • traumatic injury
  • redness and swelling
  • soreness after exercise
  • rheumatic pain
Section 55106-9

Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix . Equal volumes of each ingredient in 6X, 30X, 6C, 30C, 1LM, 2LM, 3LM potencies.

Section 60561-8

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.


Structured Label Content

Indications and Usage (34067-9)

Uses​ temporarily relieves symptoms due to injury or overexertion: bruises, muscle pain, inflammation, body aches, sprains, traumatic injury, redness and swelling, soreness after exercise, rheumatic pain.

Dosage and Administration (34068-7)

Directions:

  • Initially, depress pump until primed.
  • Spray one dose directly into mouth.
  • Adults 12 and up: 3 sprays 3 times per day.
  • Children 2-12 : 2 sprays 3 times per day.
  • Children 2 mo-2 yr: 1 spray 3 times per day.
Warnings and Precautions (34071-1)

Warnings

  • Stop use and ask your doctor if symptoms persist or worsen.
  • If pregnant or breast-feeding, take only on advice of a healthcare professional.

Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive ingredients: Bio-Energetically Enhanced pure water, Carya ovata bak extract, citrus extract, Lonicera japonica (honeysuckle), polylysine, steviol glycosides.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses temporarily relieves symptoms due to injury or overexertion:

  • bruises
  • muscle pain
  • inflammation
  • body aches
  • sprains
  • traumatic injury
  • redness and swelling
  • soreness after exercise
  • rheumatic pain
Section 55106-9 (55106-9)

Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix . Equal volumes of each ingredient in 6X, 30X, 6C, 30C, 1LM, 2LM, 3LM potencies.

Section 60561-8 (60561-8)

Tamper resistant for your protection. Use only if safety seal is intact. This product has not been clinically tested.


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Raw Label Data

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