Frida Mom – Perineal Cooling Pad Liners

Frida Mom – Perineal Cooling Pad Liners
SPL v6
SPL
SPL Set ID e9d33d92-34ee-b639-e053-2a95a90a9f36
Route
TOPICAL
Published
Effective Date 2023-01-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (8.824 g)
Inactive Ingredients
Alcohol Anhydrous Citric Acid Dehydroacetic Acid Sodium Benzoate Medium-chain Triglycerides .alpha.-tocopherol, Dl- Phenoxyethanol Water Menthyl Lactate, (-)- Glycerin Polyglyceryl-4 Caprate Potassium Sorbate Peppermint Oil Benzoic Acid Matricaria Chamomilla Flowering Top Anhydrous Trisodium Citrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-15

Description

Witch Hazel 50% w/w. Purpose: Astringent


Medication Information

Warnings and Precautions

For external use only.

When using this product:

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Indications and Usage

Directions

  • Remove one Pad Liner from pouch and place on top of maxi pad.
  • Close lid after use to retain moisture.
  • Replace Pad Liner with each maxi pad change.
Dosage and Administration

Not required.

Description

Witch Hazel 50% w/w. Purpose: Astringent

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3

Stop use and ask a doctor if:

  • Rectal bleeding occurs.
  • Condition worsens or does not improve within 7 days.
Section 51727-6

alcohol, benzoic acid, caprylic/capric triglyceride, chamomilla recutita flower extract, citric acid,dehydroacetic acid, glycerin, limonene, mentha piperita oil, menthyl lactate, phenoxyethanol, polyglyceryl-4 caprate, potassium sorbate, sodium benzoate, sodium citrate, tocopherol, water

Section 55105-1

USES: Helps relieve pain and swelling from hemorrhoids and childbirth.

Temporary relief from:

  • Irritation
  • Burning
  • Discomfort
Section 55106-9

Witch Hazel 50% w/w. Purpose: Astringent

Section 60561-8
  • Store at room temperature.
  • Close lid after every use to retain moisture.
  • Discard after every use.
  • Not flushable.
Package Label Principal Display Panel.

24 Liners. NDC: 72705-0420-1.


Structured Label Content

Indications and Usage (34067-9)

Directions

  • Remove one Pad Liner from pouch and place on top of maxi pad.
  • Close lid after use to retain moisture.
  • Replace Pad Liner with each maxi pad change.
Dosage and Administration (34068-7)

Not required.

Warnings and Precautions (34071-1)

For external use only.

When using this product:

  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Do not exceed the recommended daily dosage unless directed by a doctor.
  • Do not put this product into the rectum by using fingers or any mechanical device or applicator.
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50569-3 (50569-3)

Stop use and ask a doctor if:

  • Rectal bleeding occurs.
  • Condition worsens or does not improve within 7 days.
Section 51727-6 (51727-6)

alcohol, benzoic acid, caprylic/capric triglyceride, chamomilla recutita flower extract, citric acid,dehydroacetic acid, glycerin, limonene, mentha piperita oil, menthyl lactate, phenoxyethanol, polyglyceryl-4 caprate, potassium sorbate, sodium benzoate, sodium citrate, tocopherol, water

Section 55105-1 (55105-1)

USES: Helps relieve pain and swelling from hemorrhoids and childbirth.

Temporary relief from:

  • Irritation
  • Burning
  • Discomfort
Section 55106-9 (55106-9)

Witch Hazel 50% w/w. Purpose: Astringent

Section 60561-8 (60561-8)
  • Store at room temperature.
  • Close lid after every use to retain moisture.
  • Discard after every use.
  • Not flushable.
Package Label Principal Display Panel. (Package Label - Principal Display Panel.)

24 Liners. NDC: 72705-0420-1.


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Raw Label Data

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