84533-004 Anal Care Glo Pack

84533-004 Anal Care Glo Pack
SPL v2
SPL
SPL Set ID 26612dae-21a0-6f12-e063-6394a90afe93
Routes
RECTAL TOPICAL
Published
Effective Date 2024-11-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Sodium Sulfate Anhydrous (1.33 g) Hyaluronic Acid (0.017 g) Panthenol (0.067 g) Activated Charcoal (0.37 g) Peppermint (0.1 g) Borneol (2 g) Glycerin (6.33 g)
Inactive Ingredients
Ophiopogon Japonicus Root Lauryl Alcohol Polyglyceryl-10 Laurate Sodium Chloride Phenoxyethanol Opuntia Ficus-indica Paeonia Lactiflora Root Scutellaria Baicalensis Root Water Dmdm Hydantoin Butylene Glycol Polyethylene Glycol, Unspecified Oat Bran Polysorbate 60 Edetate Disodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-11-08

Description

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


Medication Information

Warnings and Precautions

"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.

Indications and 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.

Dosage and 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.

Description

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

Section 44425-7

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

Section 50565-1

Keep out of reach of children.

Section 50566-9

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.

Section 51727-6

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

Section 51945-4

Section 55105-1

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

Section 55106-9

Carbon 0.37%

Mirabilite 1.33%

Peppermint oil 0.1%

Borneol 2%

Glycerin 6.33%

Panthenol 0.067%

Sodium Hyaluronate 0.017%


Structured Label Content

Indications and Usage (34067-9)

"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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

"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.

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50566-9 (50566-9)

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.

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

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

Section 55106-9 (55106-9)

Carbon 0.37%

Mirabilite 1.33%

Peppermint oil 0.1%

Borneol 2%

Glycerin 6.33%

Panthenol 0.067%

Sodium Hyaluronate 0.017%


Advanced Ingredient Data


Raw Label Data

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