Label: SPORTS FOR TRAUMA- bellis perennis, hypericum perfomatum,toxicodendron pubscens leaf, ruta graveolens flowering top gel

  • NDC Code(s): 53499-6492-8
  • Packager: Schwabe North America, Inc
  • 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 October 13, 2023

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  • Active Ingredients

    Contains 5% Bellis perennis 1X

    Cotnains 5% Hypericum perforatum 2X

    Contains 5% Ruta graveolens 1X

    Contains 5% Rhus tox 4X

  • Inactive Ingredients

    Carbomer

    Ethyl Alcohol

    Eucalyptus Oil

    Purified Water

    Sodium Hydroxide

  • Dosage & Administration

    Directions

    Adults & children 6 years of age and older: apply to affected area up to 4 times daily. Rub in gently.

    Children under 6 years of age: consult a doctor.

    Patch test recommended on sensitive skin.

  • Indications & Usage

    Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with overexertion, sprains, falls, blows and minor sports injuries.

    Relieves joint and tendon pain and inflammation.

  • Purpose

    Temporarily relieves deep muscle and back pain, stiffness, and swelling associated with overexertion, sprains, falls, blows and minor sports injuries.

    Relieves joint and tendon pain and inflammation.

  • Warnings

    For external use only. Avoid contact with eyes or broken skin.

  • Do Not Use

    Do not use if hypersensitive to poison ivy (Rhus tox) or any other ingredients in this product.
    Breast-feeding women should not apply to breast area.

  • Stop Use

    Stop use and ask a doctor if skin irritation, rash or other allergic reaction develops, condition worsens or does not improve within 7 days, symptoms clear up and then occur again within a few days.

    These could be signs of a serious condition.

  • Pregnancy or Breast Feeding

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

  • Keep out of reach of children.

    Keep out of reach of children.

  • Overdose

    If swallowed, seek medical help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    LBN21825492.A01 Sports Gel.jpg

    Add image transcription here...

  • INGREDIENTS AND APPEARANCE
    SPORTS FOR TRAUMA 
    bellis perennis, hypericum perfomatum,toxicodendron pubscens leaf, ruta graveolens flowering top gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-6492
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BELLIS PERENNIS (UNII: 2HU33I03UY) (BELLIS PERENNIS - UNII:2HU33I03UY) BELLIS PERENNIS1 [hp_X]  in 70 g
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB) (HYPERICUM PERFORATUM - UNII:XK4IUX8MNB) HYPERICUM PERFORATUM2 [hp_X]  in 70 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF4 [hp_X]  in 70 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP1 [hp_X]  in 70 g
    Inactive Ingredients
    Ingredient NameStrength
    ALCOHOL (UNII: 3K9958V90M)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-6492-81 in 1 CARTON09/03/2021
    170 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/03/2021
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-6492)
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