Label: ANAL CARE GLO PACK- carbon, mirabilite, peppermint oil, borneol cream

  • NDC Code(s): 84533-004-01
  • Packager: WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 8, 2024

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

  • ACTIVE INGREDIENT

    Carbon 0.37%
    Mirabilite 1.33%
    Peppermint oil 0.1%
    Borneol 2%
    Glycerin 6.33%
    Panthenol 0.067%
    Sodium Hyaluronate 0.017%

  • PURPOSE

    Adsorbent and detoxifying, Anti-inflammatory and soothing, Cooling and analgesic, Analgesic and anti-inflammatory, Humectant and moisturizing, Healing and barrier protection, Hydration and wound healing

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

  • INDICATIONS & USAGE

    "Guard" Wash: .cleanses the anal area . refreshes the skin for a cleanfeeling.maintains natural pH balance of the skin . prepares skin for further careand treatment .suitable for daily use, promoting regular care
    "Lubricate" Pre-care: .cleanses and prepares the anorectal area beforeactivities .reduces friction ,moisturizes . provides a barrier againstirritants .protects sensitive skin from irritation
    "Oasis" After-care: .relieves anorectal itching and discomfort . alleviatespain and soreness ,reduces burning sensations . calms the anal areaafter activity.supports healing from minor irritations .reduces irritation associatedwith hemorrhoids .quickens recovery from anal fissures and proctalgia .makes bowel movements more comfortable and less painful.

  • WARNINGS

    "Guard" Wash is for external use. "Lubricate" Pre-Care and"Oasis" Post-Care is for external and/or intrarectal use."Lubricate" Pre-Care and "Oasis" Post-Care help expel fluids andgas. Mild sensations* (if occur) are normal. Use included pads tohelp avoid product contact with clothing and sheets.* such as the urge to pass gas or defecate.

  • DOSAGE & ADMINISTRATION

    Step 1: Use "Guard" Wash:Apply "Guard" Wash to the anal area. Allow it to sit for a moment,then rinse thoroughly with water.
    Step 2: Use "Lubricate" Pre-Care:Wet "Lubricate" Pre-Care in water and insert gently into theanus, which can help to clear feces and gas before activity, whileincreasing smoothness. lf needed, cleanse again with "Guard"Wash after defecation.
    Step 3: Use "Oasis" Post-Care:After wetting, apply "Oasis" Post-Care around the anal area andthen insert into the rectum. Use included pads in the box to helpavoid product contact with clothing and sheets.

  • STOP USE

    Stop use and ask a doctor if .introduction of applicator into therectum causes additional pain .condition worsens or does notimprove within seven (7) days.bleeding occurs .an allergic reaction develops .the symptombeing treated does not subside.

  • STORAGE AND HANDLING

    Store in a cool, dry place. lt is rec nended to store below 20'C(68°F).Refrigeration is advised.

  • INACTIVE INGREDIENT

    Polyethylene Glycol
    Polysorbate 60
    Cactus Extract
    Oat Bran Extract
    Ophiopogon Japonicus Root Extract
    Paeonia Lactiflora Root Extract
    Scutellaria Baicalensis Root Extract
    Water
    Sodium Chloride
    DMDM Hydantoin
    Disodium EDTA
    Polyglyceryl-10 Laurate
    Sodium Sulfate
    Butylene Glycol
    Phenoxyethanol
    Lauryl Alcohol

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    ANAL CARE GLO PACK 
    carbon, mirabilite, peppermint oil, borneol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:84533-004
    Route of AdministrationRECTAL, TOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE1.33 g  in 100 g
    HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM0.017 g  in 100 g
    PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL0.067 g  in 100 g
    ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL0.37 g  in 100 g
    PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL0.1 g  in 100 g
    BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL2 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN6.33 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    OPHIOPOGON JAPONICUS ROOT (UNII: 90PS6JV9GZ)  
    LAURYL ALCOHOL (UNII: 178A96NLP2)  
    PAEONIA LACTIFLORA ROOT (UNII: 3Z3866YW6P)  
    SCUTELLARIA BAICALENSIS ROOT (UNII: 7J95K7ID2S)  
    WATER (UNII: 059QF0KO0R)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
    OAT BRAN (UNII: KQX236OK4U)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    OPUNTIA FICUS-INDICA (UNII: 23Z87HTQ6P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:84533-004-013 g in 1 BOX; Type 1: Convenience Kit of Co-Package11/08/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/08/2024
    Labeler - WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. (412779339)
    Establishment
    NameAddressID/FEIBusiness Operations
    WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.412779339manufacture(84533-004)