Label: PLEO SANUVIS- lactic acid, l- ointment

  • 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 June 4, 2010

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  • SPL UNCLASSIFIED SECTION

    for topical use only

    Homeopathic External Analgesic Medicine

    1.05 oz (30g)

  • Indications

    For temporary relief of pain of bruises, sprains, swelling of joints and muscles.

  • DOSAGE

    Apply thinly on the affected area 1-3 times daily.

  • WARNING

    If symptoms persist more than a few days, contact a licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before using this product.

    Keep this and all other medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

    Protect fom light and heat.

    Tamper Evident

    Do not use this product if metal seal under the tube cap is missing or broken.

  • INGREDIENTS

    Active ingredients

    1g ointment contains: 0.1g Acidum L(+) - lacticum 1X.

  • Inactive ingredients

    lanolin alcohol, glycerylmonostearate, propylene glycol, polyglyceryl-3, cocoate magnesium sulfate, water.

  • SPL UNCLASSIFIED SECTION

    Made in Germany

    Distributed by:
    SANUM USA Corp.
    1465 Slater Road
    Ferndale, WA 98248

    Manufactured by:
    Sanum-Kehlbeck GmbH & Co. KG
    Hoya, Germany

    Rev. 03/2010

  • PRINCIPAL DISPLAY PANEL - 30g Tube Carton

    Pleo® Sanuvis
    Ointment 1X

    for topical use only

    Homeopathic
    External Analgesic
    Medicine

    The original
    SANUM®
    brand remedies

    Indications: For temporary
    relief of pain of bruises,
    sprains, swelling of joints
    and muscles.

    1.05 oz (30g)

    Principal Display Panel - 30g Tube Carton
  • INGREDIENTS AND APPEARANCE
    PLEO SANUVIS 
    lactic acid, l- ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:60681-6301
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    lactic acid, l- (UNII: F9S9FFU82N) (lactic acid, l- - UNII:F9S9FFU82N) lactic acid, l-1 [hp_X]  in 30 g
    Inactive Ingredients
    Ingredient NameStrength
    glyceryl monostearate (UNII: 230OU9XXE4)  
    lanolin alcohols (UNII: 884C3FA9HE)  
    water (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:60681-6301-11 in 1 CARTON
    130 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved homeopathic06/15/2010
    Labeler - Sanum Kehlbeck GmbH & Co. KG (318386133)
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