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

  • NDC Code(s): 43846-0017-1
  • Packager: Peaceful Mountain, 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 July 6, 2016

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

  • ACTIVE INGREDIENTS:

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

  • INDICATIONS:

    May temporarily relieve minor symptoms of eczema.**

    ** These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • WARNINGS:

     For external use only.

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

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

    When using this product: Do not get into eyes.

    Stop use and ask a doctor if: Condition worsens. Symptoms last more than 7 days.

    ALLERGY ALERT:  Macadamia and Kukui Nut Oils, Soy

  • DIRECTIONS:

    Apply at least 3 times daily over the affected area.

    Children under 12 years of age:  Consult a doctor

  • INACTIVE INGREDIENTS:

    Purified Water, Poke (Berry) Phytolacca Americana, Olive Oil (Olea Europaea), Avocado Oil (Persea Gratissima), Macadamia Nut Oil (Macadamia Integrifolia), Phenoxyethanol, Caprylyl Glycol, Sorbic Acid, Acrylates/C10 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, PEG-33, PEG 8 DIMETHICONE, PEG-14, Kukui Nut Oil (Aleurites Moluccana), Polysorbate 20, Chaparral Leaf (Larrea Tridentata), Poke Root (Phytolacca Americana), Arnica Montana Flower, St. Johns Wort Aerial Parts (Hypericum Perforatum), White Willow Bark (Salix Alba), Bloodroot Root (Sanguinaria Canadensis), Comfrey Leaf (Symphytum Officinale), Ascorbic Acid, Neem Leaf (Azadirachta Indica), Calendula Officinalis Flower, Vitamin E Oil, Edetate Disodium (EDTA), Oregano, Potassium Sorbate

  • 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.

  • INDICATIONS:

    May temporarily relieve minor symptoms of eczema.**

    ** These statements are based upon traditional homeopathic practice. They have not been reviewed by the Food and Drug Administration.

  • QUESTIONS

    Dist by:

    Peaceful Mountain, Inc.

    Woodbine, IA 51579    883-303-3388

    www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    peaceful mountain
    THE HEIGHT OF HEALTH

    eczema rescue

    homeopathic lotion

    formulated in boulder, co
    Net wt. 0.25 oz, (7 g)

    Eczema Rescue

  • INGREDIENTS AND APPEARANCE
    ECZEMA RESCUE 
    carbolicum acidum, fagopyrum esculentum, hydrastis canadensis, hydrocotyle asiatica, juglans regia, vinca minor lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0017
    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
    WATER (UNII: 059QF0KO0R)  
    PHYTOLACCA AMERICANA FRUIT (UNII: WE63661499)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    MACADAMIA OIL (UNII: 515610SU8C)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    PEG-8 DIMETHICONE (UNII: GIA7T764OD)  
    POLYETHYLENE GLYCOL 700 (UNII: 762678AC5R)  
    KUKUI NUT OIL (UNII: TP11QR7B8R)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    LARREA TRIDENTATA LEAF (UNII: PK0TXD049P)  
    PHYTOLACCA AMERICANA ROOT (UNII: 11E6VI8VEG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
    ST. JOHN'S WORT (UNII: UFH8805FKA)  
    SALIX ALBA BARK (UNII: 205MXS71H7)  
    SANGUINARIA CANADENSIS ROOT (UNII: N9288CD508)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    AZADIRACHTA INDICA LEAF (UNII: HKY915780T)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ORIGANUM VULGARE SUBSP. HIRTUM FLOWER (UNII: 3799SP11NY)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0017-17 g in 1 PACKET; Type 0: Not a Combination Product07/06/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic09/14/2012
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0017) , api manufacture(43846-0017) , label(43846-0017) , pack(43846-0017)