SPL v2
SPL
SPL Set ID 242277e2-ff26-ad4e-e063-6394a90ab317
Route
TOPICAL
Published
Effective Date 2024-08-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (0.5 g)
Inactive Ingredients
Potassium Sorbate

Identifiers & Packaging

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

Description

For external use only: Avoid contact with eye. If contact occurs, rinse thoroughly with water. Do not exceed the recommended daily dosage unless directed by doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator.


Medication Information

Dosage and Administration

  • Remove one liner from the pack and reseal the lid.
  • Place the liner on top of mom pad.
  • We recommend a Dr Talbot's Rapid Relief Perineal Pad.
  • Remove and dispose of the liner each time you change your pad.
  • Top up that cooling feeling with a squirt of DR Talbot's Perineal Soothing Foam as required.

Description

For external use only: Avoid contact with eye. If contact occurs, rinse thoroughly with water. Do not exceed the recommended daily dosage unless directed by doctor. Do not put this product in the rectum by using fingers or any mechanical device or applicator.

Uses
  • Helps relieve pain and swelling from hemmorrhoids and children.
  • Temperoray relief from irritation.
  • Burning
  • Discomfort

Warnings

For external use only:

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

Other Information
  • Store at room temerature
  • single use per wipe
  • close lid after every use to retain moisture
  • Not flushable

Active Ingredients

  • WITCH HAZEL 50% - ASTRINGENT

Inactive Ingredients
  • Water
  • aloe barbadensis leaf juice
  • bioflavonoids
  • calendula officinalis flower extract
  • citric acid
  • decyl glucoside
  • glycerin
  • lactic acid
  • levulinic acid
  • mentha piperita (peppermint) oil
  • sodium cocoamphoacetate
  • potassium sorbate

Cooling Perineal Pad Liner

  • SOOTHING RELIEF

Indication & Usage Section
  • ASTRINGENT
  • HELPS RELIEVES PAIN & SWELLING FROM HEMORRHOIDS & CHILDBIRTH
  • TEMPORARY RELIEF FROM IRRITATION, BURNING, DISCOMFORT

Indication and Usage Section
  • Helps relieve pain and swelling from hemorrhoids and childbirth.
  • temporary relief from Irritation, Burning, Discomfort.

Stop Use and Ask A Doctor If

  • Rectal bleeding occurs.

  • Condition worsens or does not improves within 7 days.

Keep Out of Reach of Children

If swallowed, get medical help or contract a Poison Control CEnter right away.


Structured Label Content

Uses (USES)
  • Helps relieve pain and swelling from hemmorrhoids and children.
  • Temperoray relief from irritation.
  • Burning
  • Discomfort

Dosage and Administration (34068-7)

  • Remove one liner from the pack and reseal the lid.
  • Place the liner on top of mom pad.
  • We recommend a Dr Talbot's Rapid Relief Perineal Pad.
  • Remove and dispose of the liner each time you change your pad.
  • Top up that cooling feeling with a squirt of DR Talbot's Perineal Soothing Foam as required.

Warnings (WARNINGS)

For external use only:

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

Other Information (OTHER INFORMATION)
  • Store at room temerature
  • single use per wipe
  • close lid after every use to retain moisture
  • Not flushable

Active Ingredients (ACTIVE INGREDIENTS)

  • WITCH HAZEL 50% - ASTRINGENT

Inactive Ingredients (INACTIVE INGREDIENTS)
  • Water
  • aloe barbadensis leaf juice
  • bioflavonoids
  • calendula officinalis flower extract
  • citric acid
  • decyl glucoside
  • glycerin
  • lactic acid
  • levulinic acid
  • mentha piperita (peppermint) oil
  • sodium cocoamphoacetate
  • potassium sorbate

Cooling Perineal Pad Liner (COOLING PERINEAL PAD LINER)

  • SOOTHING RELIEF

Indication & Usage Section (INDICATION & USAGE SECTION)
  • ASTRINGENT
  • HELPS RELIEVES PAIN & SWELLING FROM HEMORRHOIDS & CHILDBIRTH
  • TEMPORARY RELIEF FROM IRRITATION, BURNING, DISCOMFORT

Indication and Usage Section (INDICATION AND USAGE SECTION)
  • Helps relieve pain and swelling from hemorrhoids and childbirth.
  • temporary relief from Irritation, Burning, Discomfort.

Stop Use and Ask A Doctor If (STOP USE AND ASK A DOCTOR IF)

  • Rectal bleeding occurs.

  • Condition worsens or does not improves within 7 days.

Keep Out of Reach of Children (KEEP OUT OF REACH OF CHILDREN)

If swallowed, get medical help or contract a Poison Control CEnter right away.


Advanced Ingredient Data


Raw Label Data

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