SPL v9
SPL
SPL Set ID 3c62d081-4178-4ac0-b81f-d97202dee8ea
Route
ORAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (6 [hp_C])
Inactive Ingredients
Sucrose

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2025-05-08

Description

Arnica montana......6C HPUS


Medication Information

Warnings and Precautions

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula.
  • more than the maximum daily dosage unless directed by a doctor.
Indications and Usage

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains

Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Dosage and Administration

Directions

  • Allow pellets to dissolve slowly in the mouth.
  • Adults and children over 4 years of age: take 3 pellets orally every 6 hours.
  • Children under 4 years of age: consult a doctor.
Description

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Keep box. It contains important information. See the package insert.

Section 44425-7
  • Store at room temperature.
  • Do not use if container seal is broken.
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if:

  • condition worsens
  • a rash develops
  • symptoms persist for more than 7 days or clear up and return within a few days
Section 51727-6

Sucrose

Section 51945-4

NDC 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

150 pellets

Section 53413-1

Questions or comments? [email protected]or call 1-877-248-1970 between 9am and 5pm CST

Section 53414-9

If pregnant or breast feeding, consult a health professional.

Section 55105-1

Arnica montana.......6C HPUS*......anti-inflammatory

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" indicates a homeopathic dilution. See www.nartexlabsusa.com for more information.

Section 55106-9

Arnica montana......6C HPUS


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of:

  • sore muscles
  • bruises
  • sprains

Claims based on traditional homeopathic practice, not accepted medical evidence. These uses have not been evaluated by FDA, and product has not been clinically tested.

Dosage and Administration (34068-7)

Directions

  • Allow pellets to dissolve slowly in the mouth.
  • Adults and children over 4 years of age: take 3 pellets orally every 6 hours.
  • Children under 4 years of age: consult a doctor.
Warnings and Precautions (34071-1)

Do not use

  • if you have an allergy or hypersensitivity to the components of the formula.
  • more than the maximum daily dosage unless directed by a doctor.
Description (34089-3)

Active ingredients are prepared in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Keep box. It contains important information. See the package insert.

Section 44425-7 (44425-7)
  • Store at room temperature.
  • Do not use if container seal is broken.
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • condition worsens
  • a rash develops
  • symptoms persist for more than 7 days or clear up and return within a few days
Section 51727-6 (51727-6)

Sucrose

Section 51945-4 (51945-4)

NDC 34666-091-50

Arnica

Nartex

Pellets

For Sore muscles and bruises

Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated and not clinically tested.

Homeopathic

150 pellets

Section 53413-1 (53413-1)

Questions or comments? [email protected]or call 1-877-248-1970 between 9am and 5pm CST

Section 53414-9 (53414-9)

If pregnant or breast feeding, consult a health professional.

Section 55105-1 (55105-1)

Arnica montana.......6C HPUS*......anti-inflammatory

*The letters "HPUS" indicate that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of the United States. "C" indicates a homeopathic dilution. See www.nartexlabsusa.com for more information.

Section 55106-9 (55106-9)

Arnica montana......6C HPUS


Advanced Ingredient Data


Raw Label Data

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