Soothing Advanced Arnica™

Soothing Advanced Arnica™
SPL v1
SPL
SPL Set ID ef8ef0f9-d09b-4066-87e3-1c9356730ead
Route
TOPICAL
Published
Effective Date 2014-09-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_X]) Arnica Montana Root
Inactive Ingredients
Arnica Chamissonis Flower Cetostearyl Alcohol Water Glyceryl Monostearate Jojoba Oil Lemon Oil Phenoxyethanol Pomegranate Shea Butter Sodium Lactate Sodium Stearoyl Lactylate Almond Oil

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2012-07-18

Description

Drug Facts_ _________________________________________________________________________________________________________ HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.       


Medication Information

Warnings and Precautions

Warnings

  • For external use only. Avoid contact with eyes and broken skin.
  • Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
  • Nursing mothers should not apply to bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Indications and Usage

Uses for temporary relief of symptoms:

  • pain or stiffness in muscles or joints
  • bruising and discoloration
  • inflammation
  • soreness after exercise
Dosage and Administration

Directions

•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.

Description

Drug Facts_ _________________________________________________________________________________________________________ HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.       

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

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, lemon oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil.

Section 51945-4

Section 55105-1

 Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients                                                                       Purpose

Equal volumes of each active ingredient in 6X, 30X, 6C, and LM1 potencies.

Active ingredients 50% of total weight.

Arnica montana................................................bruises, muscle pain, stiffness

Arnica montana, radix.......................................soreness after exercise, inflammation

Section 55106-9

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.       

Section 60561-8

Other information:

  • To open: unscrew cap, remove tube seal, replace cap.
  • Safety sealed for your protection.
  • Do not use if tube seal is missing.
  • Store at 68-77° (20-25°C).

Structured Label Content

Indications and Usage (34067-9)

Uses for temporary relief of symptoms:

  • pain or stiffness in muscles or joints
  • bruising and discoloration
  • inflammation
  • soreness after exercise
Dosage and Administration (34068-7)

Directions

•Shake before using. •Apply generously to affected areas 2 to 3 times daily, or more often as needed. •Massage in thoroughly until absorbed. •For best results, apply immediately after the onset of symptoms. •Reapply after bathing and before bedtime for ongoing relief. •May be used before and after exercise.

Warnings and Precautions (34071-1)

Warnings

  • For external use only. Avoid contact with eyes and broken skin.
  • Stop use and ask a doctor if •symptoms worsen or do not improve within 7 days. •skin irritation, redness or rash occurs.
  • Nursing mothers should not apply to bre ast area.
  • Keep out of reach of children.
  • If swallowed, get medical help or contact a Poison Control Center immediately.
Section 50565-1 (50565-1)
  • Keep out of reach of children.
Section 51727-6 (51727-6)

Inactive ingredients: Cetearyl alcohol, deionized water, glyceryl stearate, jojoba seed oil, lemon oil, phenoxyethanol, pomegranate fruit extract, shea butter, sodium lactate, sodium stearoyl lactylate, sweet almond oil.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

 Drug Facts

____________________________________________________________________________________________________________________

HPUS active ingredients                                                                       Purpose

Equal volumes of each active ingredient in 6X, 30X, 6C, and LM1 potencies.

Active ingredients 50% of total weight.

Arnica montana................................................bruises, muscle pain, stiffness

Arnica montana, radix.......................................soreness after exercise, inflammation

Section 55106-9 (55106-9)

Drug Facts__________________________________________________________________________________________________________

HPUS active ingredients: Arnica montana, Arnica montana, radix. Equal volumes of each active ingredient in 6X, 30X, 6C, 30C, and LM1 potencies. Active ingredients 50% of total weight.       

Section 60561-8 (60561-8)

Other information:

  • To open: unscrew cap, remove tube seal, replace cap.
  • Safety sealed for your protection.
  • Do not use if tube seal is missing.
  • Store at 68-77° (20-25°C).

Advanced Ingredient Data


Raw Label Data

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