Belladona And Arnica Ointment
FDA Label NDC 70242-133

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dannso Corp./d.b.a. Essential Products for the product Belladona And Arnica (NDC 70242-133). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purpose, keep out of reach of children, indications and usage, warnings, directions, inactive ingredients, package label - principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Active ingredientStrengthPurpose
Menthol4%External Analgesic

Purpose

External Analgesic

Keep Out Of Reach Of Children

Keep out of the reach of children to avoid accidental poisoning.

Indications And Usage

For the temporary relief of minor pains associated with muscles and joints, backache, arthritis, strains, sprains and cramps.

Warnings

For external use only

Use only as directed.

Do not use:

  • on wounds or damaged skin
  • with a heating pad
  • on children under 12 years of age
  • on irritated skin
  • with a bandage
  • on eyes or mucous membranes

    • Ask a doctor before use if redness is present on the affected area.

    Stop use and ask a doctor if:

    • excessive irritation develops
    • condition worsens
    • symptoms persist for more than 7 days
    • symptoms clear up and occur again within a few days

      • If pregnant or breast-feeding, ask a health professional before use.

Directions

Adults and children 12 years of age or older: apply generously to affected area not more than 3 to 4 times daily.

Children under 12 years of age: ask a doctor.

Inactive Ingredients

  • Belladona extract
  • Arnica
  • Paraffin wax
  • DC Green #6
  • DC Yellow #1
  • Snow white petrolatum

Package Label - Principal Display Panel

Belladona & Arnica Analgesic Ointment Label (Belladona Arnica Label)

Belladona & Arnica Analgesic Ointment Label (Belladona Arnica Label)

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