Label: MILAGROSO- camphor ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 19, 2024

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  • Drug Facts

  • Active ingredient & Purpose

    Active ingredientPurpose

    Camphor 10 %.............................................................

    		Topical analgesic
  • Uses

    For temporary relief of minor aches and pains of muscles and joints associated with

    • back aches
    • arthritis
    • strains
    • sprains

  • Warnings

    FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

    Do not

    • apply to on wounds or damaged skin
    • bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days

    If pregnant or breast-feeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • adults & children 12 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 in a cool dry place
    • ​do not use if seal over cap is broken, torn, or missing
  • Inactive Ingredients

    cyclomethicone 5, petrolatum

  • Questions or Comments?

    1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

  • Dist. by:

    Pharmadel LLC

    Georgetown, DE 19720

  • Principal Display Panel

    MCamphor 10

  • INGREDIENTS AND APPEARANCE
    MILAGROSO 
    camphor ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-417
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) (CAMPHOR (SYNTHETIC) - UNII:5TJD82A1ET) CAMPHOR (SYNTHETIC)10 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55758-417-0257 g in 1 JAR; Type 0: Not a Combination Product04/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01704/01/2024
    Labeler - Pharmadel LLC (030129680)
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