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
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
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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.
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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
- STORAGE AND HANDLING
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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
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INGREDIENTS AND APPEARANCE
ANAL CARE GLO PACK
carbon, mirabilite, peppermint oil, borneol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:84533-004 Route of Administration RECTAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM SULFATE (UNII: 0YPR65R21J) (SODIUM SULFATE ANHYDROUS - UNII:36KCS0R750) SODIUM SULFATE 1.33 g in 100 g HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY) HYALURONATE SODIUM 0.017 g in 100 g PANTHENOL (UNII: WV9CM0O67Z) (PANTHENOL - UNII:WV9CM0O67Z) PANTHENOL 0.067 g in 100 g ACTIVATED CHARCOAL (UNII: 2P3VWU3H10) (ACTIVATED CHARCOAL - UNII:2P3VWU3H10) ACTIVATED CHARCOAL 0.37 g in 100 g PEPPERMINT OIL (UNII: AV092KU4JH) (PEPPERMINT - UNII:V95R5KMY2B) PEPPERMINT OIL 0.1 g in 100 g BORNEOL (UNII: M89NIB437X) (BORNEOL - UNII:M89NIB437X) BORNEOL 2 g in 100 g GLYCERIN (UNII: PDC6A3C0OX) (GLYCERIN - UNII:PDC6A3C0OX) GLYCERIN 6.33 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:84533-004-01 3 g in 1 BOX; Type 1: Convenience Kit of Co-Package 11/08/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug 505G(a)(3) 11/08/2024 Labeler - WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. (412779339) Establishment Name Address ID/FEI Business Operations WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd. 412779339 manufacture(84533-004)