Label: REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM- trolamine salicylate 10% lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 3, 2018

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  • Active ingredient                               Purpose

    Trolamine Salicylate - 10%                Topical Analgesic

  • Purpose

    Topical Analgesic

  • Uses

    Uses: ​temporarily relieves minor pain associated with • arthritis • simple backache •muscle strains • bruises • cramps

  • Warnings For external use only

    Allergy alert: if prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

    ​When using this product • use only as directed • avoid contact with eyes or muscous membranes • do not apply to wounds or damaged skin

    Stop use and ask a doctor if • condition worsens • symptoms persist for more than 7 days or clear up and occur again within a few days • redness is present • irritation develops

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

    Keep out of reach of the children. If product is swallowed, get medical help or contact a Poison Control Center right away

  • Directions

    adults and children over 2 years:

    • apply generously to affected area
    • massage into painful area until thoroughly absorbed into skin
    • repeat as necessary, but no more than 4 times daily

    children 2 years or younger: ask a doctor

  • Inactive ingredients:

    Aloe Barbadensis Leaf, Arnica Montana Flower Extract, Butylene Glycol, Butyrospermum Parkii (Shea Butter), C13-14 Isoparaffin, Caprylyl Glycol, Carbomer, Cetearyl Alcohol, Cetyl Alcohol, Emu Oil, Fragrance, Laureth-7, Methylsulfonylmethane, Olea Europaea (Olive) Fruit Oil, Phenoxyethanol, Polyacrylamide, Purified Water, Salix Alba (Willow) Bark Extract, Tocopheryl Acetate, Triethanolamine.

  • Package Label and Principal Display Panel

    labeling

  • INGREDIENTS AND APPEARANCE
    REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM 
    trolamine salicylate 10% lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58133-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROLAMINE SALICYLATE (UNII: H8O4040BHD) (SALICYLIC ACID - UNII:O414PZ4LPZ) TROLAMINE SALICYLATE10 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHYL SULFONE (UNII: 9H4PO4Z4FT)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    EMU OIL (UNII: 344821WD61)  
    LAURETH-7 (UNII: Z95S6G8201)  
    BUTYROSPERMOL (UNII: 6SF0L0FL42)  
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    OLEA EUROPAEA FRUIT VOLATILE OIL (UNII: 8E7358CX1J)  
    2-(2-(2-(2-PHENOXYETHOXY)ETHOXY)ETHOXY)ETHANOL (UNII: Y050HYR4XA)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58133-400-1545 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2014
    2NDC:58133-400-04120 mL in 1 TUBE; Type 0: Not a Combination Product12/16/2014
    3NDC:58133-400-12345 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product12/16/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/16/2014
    Labeler - Cosmetic Specialty Labs, Inc. (032973000)
    Registrant - Cosmetic Specialty Labs, Inc. (032973000)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Specialty Labs, Inc.032973000manufacture(58133-400)
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