Label: MY MEDIC CALENDULA- calendula officinalis flower extract gel

  • NDC Code(s): 81417-007-01
  • Packager: Sled Distribution, LLC
  • 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 January 15, 2024

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  • Active ingredients

    Calendula Officinalis Flower Extract (4%)

  • Purpose Section

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

  • Uses

    temporarily relieve muscle pain and stiffness due to:

    • minor infuries
    • overexertion
    • falls
    • reduces symptoms of bruising such as
    • discoloration
    • pain
    • swelling
  • Warnings

    For external use only.

  • DO NOT USE

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

  • WHEN USING

    When using this product

    • avoid contact with eyes, mucous membranes, wounds, damaged or irritated skin
    • dryness or irritation may occur
    • use only 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

    Stop use and ask a doctor if

    • conditions persist for more than3 days or worsens
    • symptoms clear up and occur again within a few days
  • Keep out of reach of children

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

  • Directions

    Apply a thin layer of gel to affected area as soon as possible after minor injury. Repeat 3 times a day or as needed. lf heat or ice is applied, wait 5 minutes before applying ointment.

  • Other information

    do not use if the sachet seal is broken.

  • Inactive ingredients

    White Petroleum, Water

  • PRINCIPAL DISPLAY PANEL

    image of pouch label

  • INGREDIENTS AND APPEARANCE
    MY MEDIC CALENDULA 
    calendula officinalis flower extract gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81417-007
    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
    WATER (UNII: 059QF0KO0R)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81417-007-013.5 g in 1 POUCH; Type 0: Not a Combination Product08/29/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/29/2022
    Labeler - Sled Distribution, LLC (079772888)
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