Dr. Reckeweg R53 Comedonin
FDA Label NDC 53346-1353

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 R53 Comedonin (NDC 53346-1353). 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 - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Otc - Active Ingredient

Active ingredients

Ammonium bromatum 12X, Bromium 12X, Hepar sulphuris calcareum 30X, Juglans regia 30X, Kali bromatum 12X, Ledum palustre 30X, Natrum bromatum 12X, Natrum muriaticum 200X, Placenta suis 12X, Viola tricolor 12X, 1 g each in 10 g. 

Otc - Purpose


Purpose

Relieves symptoms associated with acne


Indications & Usage


Uses

For the temporary relief of minor symptoms associated with acne such as:


  • Pimples
  • Blackheads
  • Pustules

Warnings

Warnings

Otc - Stop Use

Stop use and ask a doctor if symptoms persist, get worse, or if new symptoms occur.

Otc - Pregnancy Or Breast Feeding

If pregnant or breastfeeding, ask a health care professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children.

Dosage & Administration

Directions

Adults and children ≥ 12 years 5-10 drops 1-3 times daily in a little water or undiluted or as recommended. 

Other Safety Information


Other information


  • Tamper resistant: do not use if safety ring at base of cap is broken.
  • Retain outer carton for full product information.

Inactive Ingredient

Inactive ingredients

Ethanol, purified water.

Package Label.Principal Display Panel


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Image Of Carton Label (A8d4f9f4 D892 451e Bfee 362998860c2d)

NDC# 53346-1353-5

Dr. Reckeweg R53 Comedonin

Homeopathic preparation for the temporary relief of minor symptoms associated with acne such as:

  • Pimples
  • Blackheads
  • Pustules
  • Manufactured by:

    Dr. Reckeweg Co. GmbH

    D-64625 Bensheim

    Germany


    1.68 fl oz
    (50 ml)

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