Label: ECZEMA RESCUE- carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor gel

  • 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 February 24, 2015

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  • ACTIVE INGREDIENTS:

    Carbolicum Acidum 30X, Fagopyrum Esculentum 30X, Hydrastis Canadensis 30X, Hydrocotyle Asiatica 30X, Juglans Regia 30X, Vinca Minor 30X

  • USES:

    Helps temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning • Itching • Dry • Rough • Scaly • Chapped • Cracked skin • Rashes • Urticaria (hives) • Eruptions • Eczema • Psoriasis • Generally unhealthy skin

  • WARNINGS:

    For external use only

    When using this product

    • Do not get into eyes

    Stop use and ask a doctor if

    • Condition worsens

    • Symptoms last more than 7 days

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

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

  • KEEP OUT OF REACH OF CHILDREN:

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

  • DIRECTIONS:

    Apply at least 3 times daily over affected area. Consult a physician for use in children under 12 years of age.

  • USES:

    Helps temporarily relieve minor symptoms of eczema such as • Irritated • Red • Burning • Itching • Dry • Rough • Scaly • Chapped • Cracked skin • Rashes • Urticaria (hives) • Eruptions • Eczema • Psoriasis • Generally unhealthy skin

  • INACTIVE INGREDIENTS:

    Aloe Vera 10X Concentrate, Arnica Montana (Flower), Avocado Oil, Sanguinaria Canadensis (Root), Calendula Officinalis (Flower), Carbomer (Ultrez 21), Larrea Tridentata (Leaf), Symphytum Officinale (Leaf), Edetate Disodium (Edta), Kukui Nut Oil, Macadamia Nut Oil, Natural Plant Extract (Origanox WS), Azadirachta Indica (Leaf), Olive Oil, [Peg-33, Peg-8 Dimethicone, Peg-14 (Silsense Copolyol-1 Silicone)], Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen Plus) Phytolacca Americana (Berry), Phytolacca Americana (Root), Polysorbate 20 [Tween 20], Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Hypericum Perforatum (Aerial Parts), Vitamin C (Powder)[Ascorbic Acid], Vitamin E (Derived From Soy Bean), Salix Alba (Bark)

  • QUESTIONS:

    Dist. by:

    Peaceful Mountain, Inc.

    Woodbine, IA 51579

    888-303-3388 Mon-Fri 8a.m-5 p.m. CST

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    peaceful mountain

    THE HEIGHT OF HEALTH

    eczema rescue

    homeopathic gel

    Temporary

    soothing relief

    for symptoms of

    eczema: rash,

    burning, itching,

    chapped, dry, or

    cracked skin

    Net wt. 1 oz. (28 g)

    Eczema Rescue

  • INGREDIENTS AND APPEARANCE
    ECZEMA RESCUE 
    carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0012
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    PHENOL (UNII: 339NCG44TV) (PHENOL - UNII:339NCG44TV) PHENOL30 [hp_X]  in 1 g
    FAGOPYRUM ESCULENTUM (UNII: B10M69172N) (FAGOPYRUM ESCULENTUM - UNII:B10M69172N) FAGOPYRUM ESCULENTUM30 [hp_X]  in 1 g
    GOLDENSEAL (UNII: ZW3Z11D0JV) (GOLDENSEAL - UNII:ZW3Z11D0JV) GOLDENSEAL30 [hp_X]  in 1 g
    CENTELLA ASIATICA (UNII: 7M867G6T1U) (CENTELLA ASIATICA - UNII:7M867G6T1U) CENTELLA ASIATICA30 [hp_X]  in 1 g
    JUGLANS REGIA LEAF (UNII: 85HKB87105) (JUGLANS REGIA LEAF - UNII:85HKB87105) JUGLANS REGIA LEAF30 [hp_X]  in 1 g
    JUGLANS REGIA FRUIT RIND, IMMATURE (UNII: ZPS7Q5U53K) (JUGLANS REGIA FRUIT RIND, IMMATURE - UNII:ZPS7Q5U53K) JUGLANS REGIA FRUIT RIND, IMMATURE30 [hp_X]  in 1 g
    VINCA MINOR (UNII: WGM46PQF02) (VINCA MINOR - UNII:WGM46PQF02) VINCA MINOR30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    OREGANO (UNII: 0E5AT8T16U)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    HYPERICUM PERFORATUM (UNII: XK4IUX8MNB)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0012-128 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic02/24/2015
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0012) , api manufacture(43846-0012) , label(43846-0012) , pack(43846-0012)
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