Label: HEALING ALL-PURPOSE CREAM- calendula officinalis cream

  • NDC Code(s): 10738-032-20
  • Packager: Genuine Virgin Aloe Corporation
  • 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 31, 2023

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  • Active ingredient

    Calendula Officinalis 1X HPUS 1.5%

    HPUS indicates that this ingredient is officially included in the Homeopathic Pharmacopeia of the United States.

  • Purpose

    Speed healing, Minimizes recurrence, healing agent.

  • Uses

    •speed healing of wounds, sores, acne and lip sores •helps promote healing of cuts, scrapes, chafing, minor burns and sunburn

  • Warnings

    For external use only.

    Avoid contact with eyes.

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

    Stop use and ask a doctor before use in case of deep puncture wounds, animal bites or serious burns and if condition persists for more than 4 days or worsens.

    Keep out of reach of children. If swallowed, get medical help and contact a Poison Control Center right away.

  • Directions

    •read all package directions and warnings before use. When using this product use only as directed. Apply a thin layer to affected area and massage gently as soon as possible after minor injury. Apply 3X a day or as needed •Sensitivity Test for a New User. Apply sparingly to one or two small affected areas during the first 3 days. •if no discomfort occurs, follow the direction stated above.

  • Other information

    Do not use if glued carton end flaps are open or if the tube seal is broken. •store at room temperature.

  • Inactive ingredients

    water, cetearyl alcohol, isopropyl palmitate, polysorbate 60, cera alba(beeswax), dimethicone, allantoin, zinc PCA, avena sativa (oat) kernel flour, aloe barbadensis leaf juice, butyrospermum parkii (shea) butter, tocopheryl acetate (vitamin E), panthenol (pro-vitamin B5), cetyl alcohol, sodium PCA, sodium phytate, sodium hydroxide, phenoxyethanol, ethylhexylglycerin.

  • Questions?

    1-800-279-7282 M-F 8am-4pm PST

  • Packaging

    Triderma MD Baby

    Healing all-Purpose Cream

    Helps promote healing of cuts, scrapes, chafing, minor burns, and sunburn

    Dermatologist Tested


    Calendula

    Homeopathic Medicine

    NET WT. 2 oz (57 g)

    Carton

    Tube

  • INGREDIENTS AND APPEARANCE
    HEALING ALL-PURPOSE CREAM 
    calendula officinalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:10738-032
    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 TOP1.5 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ZINC PIDOLATE (UNII: C32PQ86DH4)  
    OATMEAL (UNII: 8PI54V663Y)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:10738-032-201 in 1 CARTON08/01/2020
    1119 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic08/01/2020
    Labeler - Genuine Virgin Aloe Corporation (961374147)
    Establishment
    NameAddressID/FEIBusiness Operations
    Genuine Virgin Aloe Corporation961374147manufacture(10738-032)
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