REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM (TROLAMINE SALICYLATE 10%) LOTION [COSMETIC SPECIALTY LABS, INC.]

  • Home
  • REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM (TROLAMINE SALICYLATE 10%) LOTION [COSMETIC SPECIALTY LABS, INC.]

REAL TIME PAIN RELIEF THERAPEUTIC HAND CREAM (TROLAMINE SALICYLATE 10%) LOTION [COSMETIC SPECIALTY LABS, INC.]
PDF | XML
NDC 58133-400-04, 58133-400-12, 58133-400-15
Set ID 61e1af5e-d782-a3b6-e053-2a91aa0ad098
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Specialty Labs, Inc.
Generic Name
Product Class
Product Number
Application Number PART348
View All Sections
  • 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)
View All Sections

Related Drugs

Search DailyMed Drugs