Label: MY MEDIC CALENDULA GEL- calendula officinalis flowers gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated April 7, 2022

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  • Purpose Section

    Relieves muscle pain and stiffness, swelling from injuries, discoloration from bruises.

  • Active Ingredients

    Calendula Officinalis Flower Extract ...... 4%

  • Indications and Usage

    temporarily relieve muscle pain and stiffness due to: 

    • minor infuries
    • overexertion 
    • falls
    • reduces symptoms of bruising such as discoloration, pain, and swelling.
  • Keep our of Reach of Children

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

  • Warning Section

    Warnings

    For external use only.

    ■ Do not use on if are allergic to Calendula or any of this product's inactive ingredients.

    When using this product

    ■ avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin.

    ■dryness or irritation may occur

    • Use on as directed
    • do not tightly wrap or bandage the treated area
    • do not apply heat or ice to the treated area immediately before or after use.

    Stop use and ask a doctor if

    • conditions persist for more than 3 days or worsens
    • symptons clear up and occur again within a few days.

  • Storange and Handling

    Store at room temperature.

  • Dosage & Administration

    apply a thin layer of gel toaffected area as soon as possible after minor injure. Repeat 3 time a day or as needed. If heat or ice is applied, wait 5 minutes before applying ointment.

  • Inactive Ingredients

    White Petroleum, Water

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    MY MEDIC  CALENDULA GEL
    calendula officinalis flowers gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD) (CALENDULA OFFICINALIS FLOWER - UNII:P0M7O4Y7YD) CALENDULA OFFICINALIS FLOWER4 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-126-013.5 g in 1 PACKAGE; Type 0: Not a Combination Product04/07/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/07/2022
    Labeler - Sled Distribution, LLC (079772888)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sled Distribution, LLC079772888manufacture(81417-126)
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