Label: OLIVE RECTAL FORMULA- olive rectal spray spray

  • Category: HUMAN PRESCRIPTION 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 6, 2017

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  • Olive Rectal Spray

    Aesculius hipp 12X

    Aloe soc 12X

    Carbo veg 12X

    Gambogia 12X

    Sulphur 30X

  • Olive Rectal Spray

    Extra Virgin Olive Oil, Natural Coconut Oil, Omega-3 Shark Live Oil, Vanilla fragrance, Natural Vitamin E

  • Olive Rectal Spray

    Ask a doctor before use if you have:

    - abdominal pain and tenderness in the lower abdomen

    - Blood in the stool or continuous bleeding

    - diarrhea, constipation, or other change in bowel habits

    - intestinal obstruction

    -narrow stools

    - weight loss with no known reason

    -possibly ruptured your rectal membrane or wall by a foreign object

    -fever chillis, nausea, vomiting

    - a family history of colon cancer

    - been exposed to the human immunodefiency virus (HIV) that causes AIDS

    -anal infections often (such as once a month or 3 in 6 months)

  • Olive Rectal Spray

    Keep out of reach of children. The ingredients in this product are 100% edible. However, this product is not meant to be swallowed, If swallowed, contact your doctor

  • Olive Rectal Spray

    A homeopathic remedy for the relief of anal and rectal irritations including external and internal itching, soreness, hemmorhoid, swelling, buring pain and abnormal dischare, that can be mixed with mucus and blood.

  • Olive Rectal Spray

    Adults and children 12 years of age and over.

    -apply a drop of product to outside of tube to lubricate tube prior to insertion.

    -insert applicater tube into anus and apply 2-3 sprays at bedtime for up to 7 days

    -lie down after applying to minimize leakage

    -additiona applications can be applied during the day as needed without any danger of overdose

    -After each use either wash applicator/tube with warm soapy water of replace with a new one

    Children under 12 years of age, ask a doctor.

  • Olive Rectal Spray

    Aesculus hipp - Dry aching rectum, Hemmorrhoids; anus raw, much pain after stool; Mucous membranes swelling and obstructing passage; buring in anus with chills up and down back.

    Aloe soc - Jelly-like stoos, with soreness in rectum after stool; mixed with mucus

    Carbo veg - itching, gnawing and burning in rectum; acrid corrosive moisture from rectum; Soreness, itching, and moister from perineum at night; buring at anus; pain after stooling

    Gambogia - Hard stool, burning at anus, yellow and green diarrhoeic stool, mixed with mucus.

    Sulpher - Anal and rectoal redness, itching, burning, pain, and stinging; discolored feces, evacuations mingled with mucous, blood; buring in anus during and after stool

  • Olive Rectal Spray

    Label

    Carton

  • INGREDIENTS AND APPEARANCE
    OLIVE RECTAL FORMULA 
    olive rectal spray spray
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:64616-056
    Route of AdministrationRECTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HORSE CHESTNUT (UNII: 3C18L6RJAZ) (HORSE CHESTNUT - UNII:3C18L6RJAZ) HORSE CHESTNUT12 [hp_X]  in 1 mL
    ALOE (UNII: V5VD430YW9) (ALOE - UNII:V5VD430YW9) ALOE12 [hp_X]  in 1 mL
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL12 [hp_X]  in 1 mL
    GAMBOGE (UNII: 7556HJ7587) (GAMBOGE - UNII:7556HJ7587) GAMBOGE12 [hp_X]  in 1 mL
    SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR30 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    SHARK LIVER OIL (UNII: 4B24275HEU)  
    VANILLA (UNII: Q74T35078H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:64616-056-021 in 1 CARTON10/02/2009
    1NDC:64616-056-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic10/02/2009
    Labeler - Vitality Works, Inc. (137752817)
    Registrant - Vitality Works, Inc. (137752817)
    Establishment
    NameAddressID/FEIBusiness Operations
    Vitality Works, Inc.137752817manufacture(64616-056)