Label: RELIEVEIT SPRAINGO GEL (arnica montana, ruta graveolens, symphytum officinale, mentha piperita- peppermint gel

  • 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 17, 2018

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Arnica montana: 1X – 7%

    Ruta graveolens: 2%

    Symphytum Officinale (Comfrey root): 2%

    Mentha Piperita: 1.25%

  • Purpose

    Significantly reduces swelling and pain

    associated with acute sprains, strains

    and muscle overexertion. Reduces

    discoloration from bruising.

  • Uses:

    Sprains, Strains, Muscle/Tendon

    Pulls, Tendonitis

  • Warnings:

    for external use only

  • When using this product:

    use only as directed • avoid contact with eyes

    or mucous membranes • do not apply to open

    wounds, damaged, or very sensitive skin • do

    not use if you are allergic to any of this product’s

    active or inactive ingredients • do not apply

    bandage tightly or use heating pad • do not

    resume normal activity without the advice of a

    • medical professionall
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact the

    Poison Control Center right away.

  • Directions:

    Adults and children 2 years and over:

    • Shake well before using •Apply a sufficient

    amount of RelieveIt® SprainGo Gel to cover the

    affected area • Repeat as needed • After

    applying, wash hands with soap and water

    Children under 2: consult a doctor

  • Other ingredients:

    Harpagophytum procumbens, Carbomer 934P,
    Cyclomethicone, C13/14 Isoparaffin, Ethyl Alcohol,
    Eucalyptus Oil, Glycerin,
    Hydroxypropylcellulose, Isopropyl Myristate, Juniper
    Oil, Laureth-7, Polyacrylamide, Polyethylene Glycol
    3350, Polysorbate 80, Propyl Gallate, Propylene
    Glycol, Purified Water, Resin, Sodium Hydroxide,
    Sorbic Acid, Wintergreen Oil and Xanthan Gum.

    *These “Uses” have not been evaluated by the
    Food & Drug Administration.

  • Stop use and ask a doctor if:

    excessive redness or irritation is present •

    condition worsens • pain persists for more than

    7 days

  • If pregnant or breast feeding:

    ask a health professional before use

  • Other Information

    Store at 68-77°F (20-25°C)

  • Principal Display Panel and Drug Facts

    Package label

  • INGREDIENTS AND APPEARANCE
    RELIEVEIT SPRAINGO GEL 
    arnica montana, ruta graveolens, symphytum officinale, mentha piperita (peppermint) gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-950
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ARNICA MONTANA (UNII: O80TY208ZW) (ARNICA MONTANA - UNII:O80TY208ZW) ARNICA MONTANA7 [hp_M]  in 1 mL
    MENTHA PIPERITA (UNII: 79M2M2UDA9) (MENTHA PIPERITA - UNII:79M2M2UDA9) MENTHA PIPERITA7 [hp_M]  in 1 mL
    SYMPHYTUM OFFICINALE WHOLE (UNII: H8FJJ6KX5Y) (SYMPHYTUM OFFICINALE WHOLE - UNII:H8FJJ6KX5Y) SYMPHYTUM OFFICINALE WHOLE2 [hp_M]  in 1 mL
    RUTA GRAVEOLENS FLOWERING TOP OIL (UNII: VDI0O08XRA) (RUTA GRAVEOLENS FLOWERING TOP OIL - UNII:VDI0O08XRA) RUTA GRAVEOLENS FLOWERING TOP OIL2 [hp_M]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    LOW-SUBSTITUTED HYDROXYPROPYL CELLULOSE, UNSPECIFIED (UNII: 2165RE0K14)  
    JUNIPER BERRY OIL (UNII: SZH16H44UY)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    BENZOIN RESIN (UNII: GK21SBA74R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PROPYLENE GLYCOL 2-METHYLBUTYRATE (UNII: QH216IX8SV)  
    POLYETHYLENE GLYCOL 3350 (UNII: G2M7P15E5P)  
    PROPYL GALLATE (UNII: 8D4SNN7V92)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SORBIC ACID (UNII: X045WJ989B)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    WATER (UNII: 059QF0KO0R)  
    AMMONIUM LAURETH-7 SULFATE (UNII: 9LPV636QCV)  
    KALANCHOE PINNATA LEAF (UNII: 3R963LO08T)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    HARPAGOPHYTUM PROCUMBENS ROOT (UNII: 1OYM338E89)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-950-0270 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
    2NDC:58133-950-16474 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
    3NDC:58133-950-373780 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product10/17/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/17/2018
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-950)