Label: RAY DOL- pain relieving cream cream

  • 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 7, 2014

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  • Drug Facts

  • Active Ingredients

    Menthol - 10%

    Methyl salicylate - 15%

  • Purpose

    Topical Analgesic

    Topical Analgesic

  • Uses

    Temporary relief of minor aches and pains of muscle and joints associated with

    • simple back aches
    • arthritis
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only

    Do not use

    • on wounds, damaged, broken or irritated skin
    • with a heating pad

    When using this product

    • use only as directed
    • avoid contact with eyes or mucous membranes
    • Do not apply bandage tightly

    Stop use and ask doctor if

    • Condition worsens, or symtoms persist for more than 7 days
    • symptoms  clear up and occur again within a few days
    • excessive skin irritation occurs
    • If pregnant or breast feeding, ask a health professional before use.
  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

  • Directions

    • Adults and children 2 years of age and older; Apply to affected area not more than 3 to 4 times daily.
    • Children under 2 years of age; consult a doctor.
  • Other information

    • Store at controlled room temperature 20°- 25°C ( 68° to 77°F)
    • Close cap tightly after use.
  • Inactive ingredients

    Carbomer, Cetyl Alcohol, Oleth-3 Phosphate, Purified Water, Stearic acid, Triethanolamine

  • Principal Display Panel - 3.0 oz Carton

    RAY DOL

    Topical Analgesic

    Greaselees Stainless

    Temporary Relief

    Penetrating temporary relief of minor muscle aches

    For Arthritis, Muscle & Joint Pain

    10% Menthol and

    15% Methyl Salicylate

    Net WT. 3.0 oz ( 85g)

    Principal Display Panel - 3.0 oz Carton

  • Principal Display Panel - 3.0 oz Tube

    RAY DOL

    Pain Relieving Cream

    Topical Analgesic

    Net WT. 3.0 oz (85g)

    Principal Display Panel - 3.0 oz Tube

  • INGREDIENTS AND APPEARANCE
    RAY DOL 
    pain relieving cream cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-057
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE150 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    OLETH-3 PHOSPHATE (UNII: 8Q0Z18J1VL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-057-731 in 1 CARTON
    185 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34812/15/2013
    Labeler - Genomma Lab USA Inc. (832323534)
    Registrant - Faria LLC dba Sheffield Pharmaceuticals (151177797)
    Establishment
    NameAddressID/FEIBusiness Operations
    Faria LLC dba Sheffield Pharmaceuticals151177797manufacture(50066-057)
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