Label: RELIEVEIT GEL- arnica montana 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 November 13, 2018

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

  • Active Ingredient

    Arnica montana 1X HPUS: 7%

  • Purpose

    Arthritis • bursitis • Fibromyalgia • Tendonitis • Joint pain/discomfort

    • Sciatica • Swelling • Muscle pulls/aches/soreness
  • Uses:

    Arthritis • Osteoarthritis • Backaches • Bursitis •

    Fibromyalgia • Tendonitis • Joint pain/discomfort

    • Sciatica • Swelling

  • 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 Arnica montana or to any of this product’s

    inactive ingredients • do not apply bandage tightly or use heating pad

  • 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® 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:

    Calendula officinalis, Carbomer 934P, Cyclomethicone, Ethyl Alcohol,
    Eucalyptus, Glycerin, Hydroxypropyl Cellulose,
    Isopropyl Myristate, Juniper Oil, Laureth-7, Polyacrylamide, Polyethylene
    Glycol 3350, Polysorbate 80, Propyl Gallate,
    Propylene Glycol, Purified Water, Resin, Sodium
    Hydroxide, Sorbic Acid, Wintergreen, 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

    3 days

  • If pregnant or breast feeding:

    ask a health professional before use

  • Other Information

    Do not use if glued carton end flaps are open or if tube seal is broken.

    Store at 68-77°F (20-25°C)

  • Principal Display Panel and Drug Facts

    carton labeling

  • INGREDIENTS AND APPEARANCE
    RELIEVEIT GEL 
    arnica montana gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-951
    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 g
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    METHYL ALCOHOL (UNII: Y4S76JWI15)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    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)  
    GAULTHERIA PROCUMBENS LEAF (UNII: 2125M16OWN)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-951-0270 g in 1 TUBE; Type 0: Not a Combination Product10/22/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/22/2018
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-951)