Label: ACNE RESCUE- borax, carbo vegetabilis, carboneum sulphuratum, causticum, natrum muriaticum, silicea gel

  • NDC Code(s): 43846-0039-1, 43846-0039-2
  • 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 January 24, 2018

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  • ACTIVE INGREDIENTS:

    Borax 30X, Carbo Vegetabilis 12X, Carboneum Sulphuratum 12X, Causticum 12X, Natrum Muriaticum 30X, Silicea 30X.

  • USES:

    Temporarily relieves symptoms associated with acne: • pimples • redness • itching • inflammation.**

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

  • 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 twice daily over affected area. Consult a physician for use in children under 12 years of age.

  • INDICATIONS:

    Temporarily relieves symptoms associated with acne: • pimples • redness • itching • inflammation.**

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

  • INACTIVE INGREDIENTS:

    Aloe Barbadensis Leaf Juice (Aloe Vera 10x Concentrate), Arnica Montana (Flower), Carbomer (Ultrez 21), Larrea Tridentata (Leaf), Symphytum Officinale (Leaf), Edetate Disodium (EDTA), Lavandula Angustifolia (Buds), Melissa Officinalis (Leaf), Natural Plant Extract (Origanox WS), [PEG-33, PEG-8 Dimethicone, PEG-14 (Silsense Copolyol-1 Silicone)], [Phenoxyethanol, Caprylyl Glycol, Sorbic Acid (Optiphen-Plus)], Phytolacca Americana (Berry), Phytolacca Americana (Root), Potassium Sorbate, Purified Water, Sodium Hydroxide (Solution), Hypericum Perforatum (Aerial Parts), Vitamin C (Powder) [Ascorbic Acid], Tocopherol [Vitamin E Oil](Derived From Soy Bean), Salix Alba (Bark), Achillea Millefolium (Flower).

  • QUESTIONS:

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

    Dist. by Peaceful Mountain, Inc., Woodbine, IA 51579 ι www.peacefulmountain.com

  • PACKAGE LABEL DISPLAY:

    acne

    rescue

    homeopathic

    gel

    Fast acting, natural

    formula providing

    temporary relief from

    unsightly skin

    conditions such as

    acne and rosacea.

    peaceful mountain

    THE HEIGHT OF HEALTH

    Net wt. 0.5 oz. (14 g)

    Acne Rescue tube

    Acne Rescue carton

    Acne Rescue tube

  • INGREDIENTS AND APPEARANCE
    ACNE RESCUE 
    borax, carbo vegetabilis, carboneum sulphuratum, causticum, natrum muriaticum, silicea gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43846-0039
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BORATE (UNII: 91MBZ8H3QO) (BORATE ION - UNII:44OAE30D22) SODIUM BORATE30 [hp_X]  in 1 g
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 g
    CARBON DISULFIDE (UNII: S54S8B99E8) (CARBON DISULFIDE - UNII:S54S8B99E8) CARBON DISULFIDE12 [hp_X]  in 1 g
    CAUSTICUM (UNII: DD5FO1WKFU) (CAUSTICUM - UNII:DD5FO1WKFU) CAUSTICUM12 [hp_X]  in 1 g
    SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE30 [hp_X]  in 1 g
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) (SILICON DIOXIDE - UNII:ETJ7Z6XBU4) SILICON DIOXIDE30 [hp_X]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
    LARREA TRIDENTATA TOP (UNII: PK0TXD049P)  
    COMFREY LEAF (UNII: DG4F8T839X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    LAVANDULA ANGUSTIFOLIA FLOWER (UNII: 19AH1RAF4M)  
    MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)  
    OREGANO (UNII: 0E5AT8T16U)  
    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)  
    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)  
    ACHILLEA MILLEFOLIUM FLOWER (UNII: YQR8R0SQEA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43846-0039-21 in 1 CARTON12/29/2014
    1NDC:43846-0039-114 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic12/29/2014
    Labeler - Peaceful Mountain, Inc. (078430707)
    Registrant - Apotheca Company (844330915)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotheca Company844330915manufacture(43846-0039) , api manufacture(43846-0039) , label(43846-0039) , pack(43846-0039)
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