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

Anal Care GLO pack by

Drug Labeling and Warnings

Anal Care GLO pack by is a Otc medication manufactured, distributed, or labeled by WU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

ANAL CARE GLO PACK 
carbon, mirabilite, peppermint oil, borneol cream

Product 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)