SPL v7
SPL
SPL Set ID 3d2355e3-7ab8-4e4b-b811-38f33336212d
Route
TOPICAL
Published
Effective Date 2010-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Arnica Montana (1.66 g) Hamamelis Virginiana Leaf
Inactive Ingredients
Glycerin Lanolin Sodium Benzoate Petrolatum Water

Identifiers & Packaging

Marketing Status
UNAPPROVED HOMEOPATHIC Active Since 2010-12-23
Description

Arnica Montana TINC Hamamelis virginica TINC

Medication Information

Warnings and Precautions

Warnings:

For external use only.

Indications and Usage

for the temporary relief of

  • sore muscles
  • bruises
  • sprains

as per homeopathic materia medica

Dosage and Administration
  • adults and children over 2 years of age and older: apply generously rubbing into the affected area
  • reapply if needed
  • children under 2 years of age: consult a physician

Description

Arnica Montana TINC Hamamelis virginica TINC

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
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops

Section 50570-1

Do not:

  • use if you have an allergy or hypersensitivity to components of the formula
  • apply to wounds or damaged skin
  • apply to children under 2 years of age



Section 51727-6

Glycerin, Lanolin wax, Sodium benzoate, Solid petrolatum, water

Section 51945-4

Homeopathic relief for sore muscles, bruises and sprains.

Section 53413-1

Questions or comments?

P.O. Box 1261, Downey CA 90240

www.nartexlabs.com

Section 55105-1

Anti-inflammatory, pain reliever

Section 55106-9

Arnica Montana TINC

Hamamelis virginica TINC

Structured Label Content

Indications and Usage (34067-9)

for the temporary relief of

  • sore muscles
  • bruises
  • sprains

as per homeopathic materia medica

Dosage and Administration (34068-7)
  • adults and children over 2 years of age and older: apply generously rubbing into the affected area
  • reapply if needed
  • children under 2 years of age: consult a physician

Warnings and Precautions (34071-1)

Warnings:

For external use only.

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
  • if symptoms persist for more than 7 days or clear up and occur again within a few days
  • rash develops

Section 50570-1 (50570-1)

Do not:

  • use if you have an allergy or hypersensitivity to components of the formula
  • apply to wounds or damaged skin
  • apply to children under 2 years of age



Section 51727-6 (51727-6)

Glycerin, Lanolin wax, Sodium benzoate, Solid petrolatum, water

Section 51945-4 (51945-4)

Homeopathic relief for sore muscles, bruises and sprains.

Section 53413-1 (53413-1)

Questions or comments?

P.O. Box 1261, Downey CA 90240

www.nartexlabs.com

Section 55105-1 (55105-1)

Anti-inflammatory, pain reliever

Section 55106-9 (55106-9)

Arnica Montana TINC

Hamamelis virginica TINC

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:09:49.031840 · Updated: 2026-03-14T23:14:47.176757