Label: OLIVE LEAF ACNE REMEDY- topical skin relief liquid

  • NDC Code(s): 64616-069-01, 64616-069-02
  • Packager: Vitality Works, 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 December 28, 2023

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  • Olive Leaf Acne Remedy

    Antimonium crudum 12X

    Calcarea sulfurica 12X

    Juglans regia 6X

    Sulphur iodatum 30X

  • Olive Leaf Acne Remedy

    USP Purified Water, Xylitol powder, Sodium Chloride, Olive Leaf Extract (Olea europa) 4X, Grapefruit Seed Extract, Sodium Hydroxide (for pH balance)

  • Olive Leaf Acne Remedy

    -Do not apply in or around eyes. This product will sting your eyes. If product should get into your eyes, rinse with warm water.

    -As with any drug. If you are pregnanat or nursing a baby, seek the advice of a health care professional before using this product.

    -In case of accidental overdose by ingestion, seek profesional assistance or contact a poison control center immediately. All the ingredients are edible. However this product is not designed for internal use.

  • Olive Leaf Acne Remedy

    Keep this and all drugs out of the reach of children. For children under 3 years of age, consult a health care professional.

  • Olive Leaf Acne Remedy

    For the temporary relief of symptoms of acne, pimples, and cold sores.

    For the temporary relief of eczema, burning and itching, and skin pustular eruptions.

  • Olive Leaf Acne Remedy

    - First, thoroughly wash hands and the affected areas of the skin with warm soapy water, and rinse. Dry thoroughly.
    - Apply a drop to fingertip and gently apply on affected skin.
    - Repeat 2-3 times per day.
    - For best results, continue using for a least one week after syptoms disappear.
    - Reapply if symptoms return.

  • Olive Leaf Acne Remedy

    Antimonium crudum - Relieves pimples; pustular eruptions with burning and itching; eczema

    Calcarea sulfurica - Relieves pimples and pustules on the face and under hair

    Juglans regia - Relives acne; itching; pimples on face, neck, shoulder and back

    Sulphur iodatum - Relieves acne, itching; cold sores on lips; pustules on uppler lip

  • Olive Leaf Acne Remedy

    Olive Leaf Acne Remedy Carton

  • INGREDIENTS AND APPEARANCE
    OLIVE LEAF ACNE REMEDY 
    topical skin relief liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:64616-069
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ANTIMONY TRISULFIDE (UNII: F79059A38U) (ANTIMONY TRISULFIDE - UNII:F79059A38U) ANTIMONY TRISULFIDE12 [hp_X]  in 1 mL
    CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE ANHYDROUS12 [hp_X]  in 1 mL
    JUGLANS REGIA FLOWERING TOP (UNII: 3BA2N709NG) (JUGLANS REGIA FLOWERING TOP - UNII:3BA2N709NG) JUGLANS REGIA FLOWERING TOP6 [hp_X]  in 1 mL
    SULFUR IODIDE (UNII: L6L8KA2AA0) (SULFUR IODIDE - UNII:L6L8KA2AA0) SULFUR IODIDE30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    WATER (UNII: 059QF0KO0R)  
    OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    MAGNESIUM DISODIUM EDTA (UNII: NDT563S5VZ)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-069-021 in 1 CARTON04/20/2011
    1NDC:64616-069-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/20/2011
    Labeler - Vitality Works, Inc (137752817)
    Registrant - Vitality Works, Inc (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc137752817manufacture(64616-069)