Label: XRAY DOL- camphor, menthol, and methyl salicylate 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 June 2, 2022

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  • ACTIVE INGREDIENT

    Active ingredients Purposes

    Camphor 4%...................................Topical analgesic

    Menthol 10%...................................Topical analgesic

    Methyl salicylate 30%......................Topical analgesic

  • PURPOSE

    Uses

    • temporarily relieves the minor aches and pains of muscles and joints associated with
    • sprains
    • simple backache
    • arthritis
    • strains
    • bruises
  • WARNINGS

    Warnings

    For external use only

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

  • DO NOT USE

    Do not use

    • on wounds or damaged skin
    • with a heating pad
    • on a child under 12 years of age with arthritis-like conditions
  • ASK DOCTOR

    Ask a doctor before use if you have redness over the affected area.

  • WHEN USING

    When using this product

    • do not use otherwise than as directed
    • avoid contain with the eyes, mucous membranes or rashes
    • do not bandage tightly
  • PREGNANCY OR BREAST FEEDING

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away

  • INDICATIONS & USAGE

    Directions

    • use only as directed
    • adults and children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age: ask a doctor
  • STORAGE AND HANDLING

    Other information

    store at room temperature 20-25°C (68-77°F)

  • INACTIVE INGREDIENT

    Inactive ingredients

    ethylparaben, glyceryl monostearate, polysorbate 80, purified water, sorbitan monooleate, stearic acid

  • DOSAGE & ADMINISTRATION

    Distributed by

    Genomma Lab USA, Inc.

    Made in China

  • PRINCIPAL DISPLAY PANEL

    6454

  • INGREDIENTS AND APPEARANCE
    XRAY DOL 
    camphor, menthol, and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50066-454
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)40 mg  in 1 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL100 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) 300 mg  in 1 g
    ETHYLPARABEN (UNII: 14255EXE39)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOOLEATE (UNII: 06XEA2VD56)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50066-454-561 in 1 CARTON06/02/2022
    156.7 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34806/02/2022
    Labeler - Genomma Lab USA, Inc. (832323534)
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