Arnica Power

Arnica Power
SPL v8
SPL
SPL Set ID 48c84c56-1179-4be5-84aa-033ddcb8e80c
Route
ORAL
Published
Effective Date 2021-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (3 [hp_X])
Inactive Ingredients
Glycerin Alcohol Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2019-03-08

Description

Arnica Montana 3X, 4X, 6X.

Purpose

Temporarily relieves symptoms associated with overexertion or trauma, such as: • muscle aches • stiffness • swelling from injuries • bruising


Medication Information

Purpose

Temporarily relieves symptoms associated with overexertion or trauma, such as: • muscle aches • stiffness • swelling from injuries • bruising

Description

Arnica Montana 3X, 4X, 6X.

Purpose:

Temporarily relieves symptoms associated with overexertion or trauma, such as:

• muscle aches

• stiffness

• swelling from injuries

• bruising

Warnings:

If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Questions:

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20878 1.800.377.5787

www.sprayology.com

Directions:

Adults and children over 12: 2 sprays into the mouth 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed.

Children Under 12: consult a healthcare professional.

Indications:

Temporarily relieves symptoms associated with overexertion or trauma, such as:

  • muscle aches
  • stiffness
  • swelling from injuries
  • bruising

° natural

° gluten & lactose free

° no artificial flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Other Information:

Do not use if the transparent seal around spray bottle is broken or missing.

Active Ingredients:

Arnica Montana 3X, 4X, 6X.

Inactive Ingredients:

Non-GMO G=glycerin, organic alcohol 20% v/v, purified water.

Package Label Display:

Sprayology

Arnica Power3

RELIEVES MUSCLE PAIN + BRUISING

HOMEOPATHIC ORAL SPRAY

1.38 fl. oz (41 ml)

Keep Out of Reach of Children:

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.


Structured Label Content

Purpose: (PURPOSE:)

Temporarily relieves symptoms associated with overexertion or trauma, such as:

• muscle aches

• stiffness

• swelling from injuries

• bruising

Warnings: (WARNINGS:)

If symptoms persist or worsen, stop use and seek advice of physician. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.

Questions: (QUESTIONS:)

Mfd. for Eight and Company L.L.C.

Gaithersburg, MD 20878 1.800.377.5787

www.sprayology.com

Directions: (DIRECTIONS:)

Adults and children over 12: 2 sprays into the mouth 3 times per day. For additional symptom relief spray directly  on the affected area and massage gently into the skin. Repeat 3 times a day or as needed.

Children Under 12: consult a healthcare professional.

Indications: (INDICATIONS:)

Temporarily relieves symptoms associated with overexertion or trauma, such as:

  • muscle aches
  • stiffness
  • swelling from injuries
  • bruising

° natural

° gluten & lactose free

° no artificial flavors or colors

° vegan

° no known negative side effects

° no known negative drug interactions

Other Information: (OTHER INFORMATION:)

Do not use if the transparent seal around spray bottle is broken or missing.

Active Ingredients: (ACTIVE INGREDIENTS:)

Arnica Montana 3X, 4X, 6X.

Inactive Ingredients: (INACTIVE INGREDIENTS:)

Non-GMO G=glycerin, organic alcohol 20% v/v, purified water.

Package Label Display: (PACKAGE LABEL DISPLAY:)

Sprayology

Arnica Power3

RELIEVES MUSCLE PAIN + BRUISING

HOMEOPATHIC ORAL SPRAY

1.38 fl. oz (41 ml)

Keep Out of Reach of Children: (KEEP OUT OF REACH OF CHILDREN:)

Keep out of reach of children. Contains alcohol, in case of overdose, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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