ROSACEA SYMPTOM RELIEF (CALENDULA OFFICINALIS, CARDIOSPERMUM, CHAMOMILLA, HYDROCOTYLE ASIATICA, RHUS TOX, THUJA OCCIDENTALIS) CREAM [KING BIO INC.]

ROSACEA SYMPTOM RELIEF (CALENDULA OFFICINALIS, CARDIOSPERMUM, CHAMOMILLA, HYDROCOTYLE ASIATICA, RHUS TOX, THUJA OCCIDENTALIS) CREAM [KING BIO INC.]
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NDC 57955-0919-3
Set ID a6569a43-a207-4a5f-b059-8964f5732ae1
Category HUMAN OTC DRUG LABEL
Packager King Bio Inc.
Generic Name
Product Class
Product Number
Application Number
  • 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.

    Calendula officinalis, Cardiospermum (2X, 10X, 20X, 30X), Chamomilla, Hydrocotyle asiatica, Rhus tox, Thuja occidentalis (3X, 10X, 20X, 30X).

    *"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 rosacea: •facial redness •burning •stinging •allergic skin eruptions •itching •dermatitis •pimples •swelling •thickening of skin.

    † 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, pimples, redness 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. 

    Calendula officinalis........................................................................burning, stinging, puffy face

    Cardiospermum (2X, 10X, 20X, 30X)......................................flush of heat, allergic skin eruptions

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

    Hydrocotyle asiatica.....................................................rosacea, skin disorders, thickening of skin

    Rhus tox...................................................swelling, redness, pimples, itching, dermatitis, rosacea

    Thuja occidentalis (3X, 10X, 20X, 30X).............long-term skin troubles, sensitive skin, burning heat

    and facial redness

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ROSACEA SYMPTOM RELIEF 
    calendula officinalis, cardiospermum, chamomilla, hydrocotyle asiatica, rhus tox, thuja occidentalis cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57955-0919
    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 TOP10 [hp_X]  in 83 g
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR) (CARDIOSPERMUM HALICACABUM FLOWERING TOP - UNII:MZP2508BRR) CARDIOSPERMUM HALICACABUM FLOWERING TOP2 [hp_X]  in 83 g
    MATRICARIA RECUTITA (UNII: G0R4UBI2ZZ) (MATRICARIA RECUTITA - UNII:G0R4UBI2ZZ) MATRICARIA RECUTITA10 [hp_X]  in 83 g
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA10 [hp_X]  in 83 g
    TOXICODENDRON PUBESCENS LEAF (UNII: 6IO182RP7A) (TOXICODENDRON PUBESCENS LEAF - UNII:6IO182RP7A) TOXICODENDRON PUBESCENS LEAF10 [hp_X]  in 83 g
    THUJA OCCIDENTALIS LEAFY TWIG (UNII: 1NT28V9397) (THUJA OCCIDENTALIS LEAFY TWIG - UNII:1NT28V9397) THUJA OCCIDENTALIS LEAFY TWIG3 [hp_X]  in 83 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    OATMEAL (UNII: 8PI54V663Y)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    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:57955-0919-31 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(57955-0919)

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