Dr. Reckeweg R30 Atomare Beckeron
FDA Label NDC 53346-1330

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmazeutische Fabrik Dr. Reckeweg & Co for the product Dr. Reckeweg R30 Atomare Beckeron (NDC 53346-1330). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients

Camphora 3X 1 g, Arnica montana, radix 3X, Belladonna 3X, Calendula officinalis 3X, Dulcamara 3X, Echinacea 3X, Hamamelis virginiana 3X, Hypericum perforatum 3X, Millefolium 3X, Nux vomica 4X, Rhus tocicodendron 3X, 0.1 g each, in 100 g.

Otc - Purpose

Purpose

Relieves muscle and joint pain, sports injuries and bruising

Indications & Usage

Uses

For the temporary relief of:

  • Muscle and joint pain
  • Sports injuries and bruising

Warnings

Warnings

For external use only

Allergy alert:

  • allergic skin reactions or contact dermatitis are possible.

Otc - Do Not Use

Do not use

  • if hypersensitive to plants of the Anacardiaceae family
  • if hypersensitive to arnica or rosemary
  • during pregnancy
  • in patients with bronchial asthma or whooping cough
  • in children under the age of 5 years
  • in the area of the breasts when breastfeeding

Otc - When Using

When using this product

  • skin and mucous membrane irritation may occur
  • bronchospasms may be intensified
  • avoid contact with eyes
  • do not apply the ointment in the area on the face, particularly the nose
  • apply only to intact, uninjured skin
  • do not apply to mucous membranes
  • the application of external heat may result in excessive irritation or burning.

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens, or if symptoms persist for more than 7 days, or clear up and occur again within a few days
  • irritation occurs.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions
Adults and children ≥ 5 years: apply ointment over the affected area 2-3 times daily, or as recommended.

Not recommended for children under 5 years of age.

Other Safety Information

Other information

  • Wash hands thoroughly after use.
  • Tamper resistant: do not use if safety seal is broken.
  • Retain outer carton for full product information.

Inactive Ingredient

Inactive ingredients

Cetostearyl alcohol, lavender oil, olive oil, petrolatum, rosemary oil, scots pine oil, wool wax alcohol.

Package Label.Principal Display Panel


Image Of Carton Label (Ec13cadd 84f7 49bf Af16 Ffc2f6a8f731)

Image Of Carton Label (Ec13cadd 84f7 49bf Af16 Ffc2f6a8f731)

NDC# 53346-1330-1

DR. RECKEWEG R30 Atomare Beckeron

Pain relieving cream

Homeopathic preparation for the temporary relief of:

  • muscle and joint pain
  • sports injuries and bruising.

    • Manufactured by:

    Pharmazeutische Fabrik Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany

    www.reckeweg.de

    Net Weight: 3 oz (85 g)

* Please review the disclaimer below.