Label: HEALTHY BACK INSTITUTE RUB ON RELIEF- analgesic cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 3, 2024

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

  • Active Ingredient

    Menthol 5%

    Camphor 3%

    Purpose

    Topical Analgesic

  • Uses:

    For Temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises, and sprains.

  • WARNINGS:

    For external use only ▪Avoid contact with the eyes ▪ Do not apply to wounds or bandaged skin ▪ Do not bandage

    Stop use and consult a doctor if: ▪ condition worsens ▪ symptoms persist for more than 7 days or clear up and reoccur ▪redness is present ▪irritation develops

    Keep out of reach of children

    Keep out of the reach of children.
    If accidentally swallowed get medical help or contact a Poison Control Center immediately.

    If pregnant or breast-feeding:

    If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. If accidentally swallowed, get medical help or contact a Poison Control Center immediately

    Stop Usage immediately and as a doctor if:

    The condition worsens or symptoms persist for more than 7 days or clear up and reoccur, redness or swelling is present, irritation develops

  • WHEN USING THIS PRODUCT

    When using this product ▪ use only as directed ▪ do not apply heat (heating pads) or apply patches to area ▪ do not use with other topical analgesics - avoid contact with eyes, mucos membranes, and genital area - Do not expose application site to heat or direct sunlight

  • Other Information

    Flammable: Keep away from excessive heat or open flame. Keep out of direct sunlight: Store at 50-86F (15-30C)

  • Directions:

    Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily. Children under 12 years of age consult a doctor.

  • Inactive Ingredients:

    Aloe Barbadensis Inner Leaf Juice, Aqua, Arnica Montana Flower Extract, Ricinus Communis (Castor) Seed Oil, Cetyl Myristoleate, Glycerin USP, Caprylyl Glycol, Glyceryl Laurate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Methyl Sulfonyl Methane, Palmitoylethanolamide, Butyrospermum Parkii (Shea) Butter, D-Alpha Tocopheryl Acetate, Curcuma Longa (Turmeric) Root Extract, Salix Alba (Willow) Bark Extract.

  • RUB THE PAIN AWAY

    HBI Rub On Relief 3OZ LabelRub On Relief Net Wt 3.0 OZ (88mL)

  • INGREDIENTS AND APPEARANCE
    HEALTHY BACK INSTITUTE RUB ON RELIEF 
    analgesic cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79804-618
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL0.05 g  in 1 g
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)0.03 g  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    CETYL MYRISTOLEATE (UNII: 87P8K33Q5X)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL LAURATE (UNII: Y98611C087)  
    GLYCERYL RICINOLEATE (UNII: ZUE0CEL42O)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) (UNII: 86FQE96TZ4)  
    LAVENDER OIL (UNII: ZBP1YXW0H8)  
    DEMETON-S-METHYLSULFONE (UNII: RSO143122K)  
    1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)) (UNII: F72017VPR7)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    WILLOW BARK (UNII: S883J9JDYX)  
    DISODIUM .ALPHA.-TOCOPHERYL PHOSPHATE, D- (UNII: 7D2U5UV9RA)  
    TURMERIC (UNII: 856YO1Z64F)  
    Product Characteristics
    Colorwhite (White to off white - opaque) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79804-618-0387.1 g in 1 PACKAGE; Type 0: Not a Combination Product06/03/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/03/2024
    Labeler - Eagle Labs Inc. (118496872)
    Registrant - Eagle Labs Inc (118496872)