Label: CALIFLORA- calendula officinalis gel

  • NDC Code(s): 53499-5190-4, 53499-5190-8
  • Packager: Schwabe North America, Inc
  • 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 May 3, 2022

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  • Active ingredient

    Contains 10% CALENDULA OFFICINALIS 1X

  • Inactive Ingredient

    CARBOMER 
    ETHYL ALCOHOL
    PURIFIED WATER
    SODIUM HYDROXIDE
    WITCH HAZEL DISTILLATE

  • Dosage & Administration

    Apply think layer to affected area. For best results, use promptly after injury or trauma occurs.

    For minor burns, first run cool water on the burn area and dry.

    For minor skin irritation, first wash the area with mild soap, rinse and dry.

    Adults and children 2 years of age and older: Apply to affected area. Repeat as necessary.

    Children under 2 years of age: Consult a doctor

    Patch test recommended on sensitive skin.

  • Indications and Use

    Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.
    Helps promote healing of minor burns and skin irritations.

  • Purpose

    Temporarily relieves pain and itch associated with sunburn, windburn and chapped skin.
    Helps promote healing of minor burns and skin irritations.

  • Warning

    For external use only.  Avoid contact with eyes.

  • Do not use

    Do not use on broken skin. Do not use if hypersensitive to any ingredients in this product.
    Breast-feeding women shoud ot apply to breast area.

  • Ask doctor

    Ask a doctor before use in case of deep cuts or puncture wounds, animal bites or serious burns.

  • Pregnancy or breast feeding

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

  • Keep out of reach children

    Keep out of reach of children.

  • Overdose

    If swallowed, seek meidcal help or contact a Poison Control Center immediately.

  • PRINCIPAL DISPLAY PANEL

    LBN21825197.A01 Z Califlora Gel 2.75 oz.jpg

  • INGREDIENTS AND APPEARANCE
    CALIFLORA 
    calendula officinalis gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53499-5190
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALENDULA OFFICINALIS FLOWERING TOP (UNII: 18E7415PXQ) (CALENDULA OFFICINALIS FLOWERING TOP - UNII:18E7415PXQ) CALENDULA OFFICINALIS FLOWERING TOP1 [hp_X]  in 78 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    ALCOHOL (UNII: 3K9958V90M)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WITCH HAZEL (UNII: 101I4J0U34)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53499-5190-81 in 1 CARTON01/01/200603/31/2025
    178 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:53499-5190-41 in 1 CARTON01/01/200603/31/2025
    228 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic01/01/200603/31/2025
    Labeler - Schwabe North America, Inc (831153908)
    Establishment
    NameAddressID/FEIBusiness Operations
    Schwabe Mexico, S.A. de C.V.812805901manufacture(53499-5190)
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