Label: PSORIASIS SYMPTOM RELIEF- cardiospermum, chamomilla, glycyrrhiza glabra, hydrocotyle asiatica, lappa major, phytolacca decandra, rumex crispus, ruta graveolens, taraxacum officinale cream

  • 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 20, 2017

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Drug Facts__________________________________________________________________________________________________________

    HPUS active ingredient                                                                  Purpose† 

    Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

    Active ingredients 50% of total weight.

    Cardiospermum* (2X, 10X, 20X, 30X), Chamomilla*, Glycyrrhiza glabra, Hydrocotyle asiatica*, Lappa major*, Phytolacca decandra*, Rumex crispus*, Ruta graveolens*, Taraxacum officinale*.

    *Certified Organic ingredient

    *"HPUS" indicates the active ingredients are in the official Homeopathic Pharmacopoeia of the United States.

  • INDICATIONS & USAGE

    Uses for temporary relief of multiple symptoms of psoriasis: •itching •rash •redness •thickening of skin •exfoliation of scales and crusts •allergic skin eruptions.

    † as per various homeopathic materia medicas. These uses have not been evaluated by the FDA, and product has not been clinically tested.

  • WARNINGS

    Warnings

    • For external use only. Avoid contact with eyes.
    • Stop use and ask a doctor if •increased skin irritation or other allergic reaction develops. •symptoms worsen or do not improve within 7 days.
    • Nursing mothers should not apply to breast area.
    • Keep out of reach of children.
    • If swallowed, get medical help or contact a Poison Control Center immediately.
  • KEEP OUT OF REACH OF CHILDREN

    • Keep out of reach of children.
  • DOSAGE & ADMINISTRATION

    Directions

    •Shake before using. •Adults & children 2 years of age and older: apply to affected area up to 4 times daily. Rub in gently. •Children under 2 years of age: consult a doctor. •Patch test recommended on sensitive skin.

  • OTHER SAFETY INFORMATION

    Other information:

    • To open: unscrew cap, remove tube seal, replace cap.
    • Safety sealed for your protection.
    • Do not use if tube seal is missing.
    • Store at 68-77° (20-25°C).
    • Certified organic topical lotion.
  • INACTIVE INGREDIENT

    Inactive ingredients:​ Aloe vera leaf juice powder*, avena sativa oat kernel flour*, carrageenan, chamomile​ recutita flower extract*, citrus extract*, glycerin, green tea extract*, honeysuckle extract*, lecithin*, licorice root extract*, neem seed oil*, oregon grape root extract*, organic alcohol*, oryza sativa race bran extract*, silicon dioxide, sucrose cocoate, sunflower oil*, water, xanthan gum.

    *Certified organic Ingredient.

    Certified organic by Oregon Tilth.

  • PURPOSE

    __________________________________________________________________________________________________________

    HPUS active ingredient                                                              Purpose†

    Equal volumes of each active ingredient in 10X, 20X, and 30X potencies, unless otherwise noted.

    Active ingredients 50% of total weight. 

    Cardiospermum* (2X, 10X, 20X, 30X).....................................................allergic skin eruptions

    Chamomilla.................................................................................................red and hot skin

    Glycyrrhiza glabra*.................................................................................................psoriasis

    Hydrocotyle asiatica*.................................dry eruptions, thickening of skin, exfoliation of scales

    Lappa major...........................................................................................greyish white crusts

    Phytolacca decandra...........................................................scaly eruption, itchy, dry skin, rash

    Rumex crispus................................................................................................intense itching

    Ruta graveolens....................................................................................inflamed, itching skin

    Taraxacum officinale...................................................................severe itching, unhealthy skin

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    PSORIASIS SYMPTOM RELIEF 
    cardiospermum, chamomilla, glycyrrhiza glabra, hydrocotyle asiatica, lappa major, phytolacca decandra, rumex crispus, ruta graveolens, taraxacum officinale cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0920
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP2 [hp_X]  in 85 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 85 g
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) (GLYCYRRHIZA GLABRA - UNII:2788Z9758H) GLYCYRRHIZA GLABRA10 [hp_X]  in 85 g
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA10 [hp_X]  in 85 g
    ARCTIUM LAPPA ROOT (UNII: 597E9BI3Z3) (ARCTIUM LAPPA ROOT - UNII:597E9BI3Z3) ARCTIUM LAPPA ROOT10 [hp_X]  in 85 g
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG) (PHYTOLACCA AMERICANA ROOT - UNII:11E6VI8VEG) PHYTOLACCA AMERICANA ROOT10 [hp_X]  in 85 g
    RUMEX CRISPUS ROOT (UNII: 9N1RM2S62C) (RUMEX CRISPUS ROOT - UNII:9N1RM2S62C) RUMEX CRISPUS ROOT10 [hp_X]  in 85 g
    RUTA GRAVEOLENS FLOWERING TOP (UNII: N94C2U587S) (RUTA GRAVEOLENS FLOWERING TOP - UNII:N94C2U587S) RUTA GRAVEOLENS FLOWERING TOP10 [hp_X]  in 85 g
    TARAXACUM OFFICINALE (UNII: 39981FM375) (TARAXACUM OFFICINALE - UNII:39981FM375) TARAXACUM OFFICINALE10 [hp_X]  in 85 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OATMEAL (UNII: 8PI54V663Y)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CITRUS BIOFLAVONOIDS (UNII: BD70459I50)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    LICORICE (UNII: 61ZBX54883)  
    AZADIRACHTA INDICA SEED OIL (UNII: 4DKJ9B3K2T)  
    MAHONIA AQUIFOLIUM ROOT (UNII: 746TB9VNDP)  
    ALCOHOL (UNII: 3K9958V90M)  
    RICE BRAN (UNII: R60QEP13IC)  
    WATER (UNII: 059QF0KO0R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE COCOATE (UNII: 3H18P0UK73)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57955-0920-31 in 1 CARTON03/01/2017
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic03/01/2017
    Labeler - King Bio Inc. (617901350)
    Registrant - King Bio Inc. (617901350)
    Establishment
    NameAddressID/FEIBusiness Operations
    King Bio Inc.617901350manufacture(57955-0920)