RAY DOL (PAIN RELIEVING CREAM) CREAM [GENOMMA LAB USA INC.]

RAY DOL (PAIN RELIEVING CREAM) CREAM [GENOMMA LAB USA INC.]
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NDC 50066-057-73
Set ID ed7ee9b0-c64f-4c46-a08f-dc47fe73c381
Category HUMAN OTC DRUG LABEL
Packager Genomma Lab USA Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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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