Label: DR. RECKEWEG R53 COMEDONIN COMBINATION PRODUCT- 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 liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 4, 2013

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  • 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. 

  • 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

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

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

    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.

  • QUESTIONS


    Questions?

    Call 1-800-361-7872 or email questions@reckeweg.com



  • PRINCIPAL DISPLAY PANEL


    image of carton label

    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)

  • INGREDIENTS AND APPEARANCE
    DR. RECKEWEG R53 COMEDONIN  COMBINATION PRODUCT
    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 liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53346-1353
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AMMONIUM BROMIDE (UNII: R0JB3224WS) (BROMIDE ION - UNII:952902IX06) AMMONIUM BROMIDE12 [hp_X]  in 50 mL
    BROMINE (UNII: SBV4XY874G) (BROMINE - UNII:SBV4XY874G) BROMINE12 [hp_X]  in 50 mL
    CALCIUM SULFIDE (UNII: 1MBW07J51Q) (CALCIUM SULFIDE - UNII:1MBW07J51Q) CALCIUM SULFIDE30 [hp_X]  in 50 mL
    ENGLISH WALNUT (UNII: 1V3SHR7QB7) (ENGLISH WALNUT - UNII:1V3SHR7QB7) ENGLISH WALNUT30 [hp_X]  in 50 mL
    POTASSIUM BROMIDE (UNII: OSD78555ZM) (BROMIDE ION - UNII:952902IX06) POTASSIUM BROMIDE12 [hp_X]  in 50 mL
    LEDUM PALUSTRE TWIG (UNII: 877L01IZ0P) (LEDUM PALUSTRE TWIG - UNII:877L01IZ0P) LEDUM PALUSTRE TWIG30 [hp_X]  in 50 mL
    SODIUM BROMIDE (UNII: LC1V549NOM) (BROMIDE ION - UNII:952902IX06) SODIUM BROMIDE12 [hp_X]  in 50 mL
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698, SODIUM CATION - UNII:LYR4M0NH37) SODIUM CHLORIDE200 [hp_X]  in 50 mL
    SUS SCROFA PLACENTA (UNII: C8CV8867O8) (SUS SCROFA PLACENTA - UNII:C8CV8867O8) SUS SCROFA PLACENTA12 [hp_X]  in 50 mL
    VIOLA TRICOLOR (UNII: 9Q24RAI43V) (VIOLA TRICOLOR - UNII:9Q24RAI43V) VIOLA TRICOLOR12 [hp_X]  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53346-1353-550 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic06/01/1986
    Labeler - PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO (318602612)
    Establishment
    NameAddressID/FEIBusiness Operations
    PHARMAZEUTISCHE FABRIK DR. RECKEWEG & CO318602612manufacture(53346-1353)
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