Otc - Active Ingredient
Carbon 0.37%
Mirabilite 1.33%
Peppermint oil 0.1%
Borneol 2%
Glycerin 6.33%
Panthenol 0.067%
Sodium Hyaluronate 0.017%
Anal Care Glo Pack Cream
FDA Label NDC 84533-004
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Wu Xi Zhong Zhi Wei Na Technology Co., Ltd. for the product Anal Care Glo Pack (NDC 84533-004). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, otc - stop use, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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.
Otc - 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
Package Label.Principal Display Panel
Label (Label)
* Please review the disclaimer below.
