SPL v3
SPL
SPL Set ID 1523f52f-6a5b-a12d-e063-6294a90a4496
Route
TOPICAL
Published
Effective Date 2024-04-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 mg)
Inactive Ingredients
Aloe Vera Leaf Anhydrous Citric Acid Cocos Nucifera Whole Decyl Glucoside Glycerin Phenoxyethanol Sodium Benzoate Water Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-02

Description

Witch Hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch Hazel 50%

Uses
  • helps relieve the local itching and discomfort associated with hemmorhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas

Warnings

For external use only

Directions
  • adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use upto 6 times daily or after each bowel movement and before applying hemmorhoidal treatments and then discard.
  • children under 12 years of age consult a doctor
  • Flush or dispose of wipe in thrash
  • For best results flush no more than one wipe at a time
Active Ingredient

Witch Hazel 50%

Other Information
  • store at room temperature 20 - 25 ºC (68 - 77ºF)
  • for vaginal care- cleanse the area by gently wiping, patting or blotting. Repeat as needed
  • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutesand repeat as needed.
Inactive Ingredients

aloe barbadensis leaf extract, citric acid, cocos nucifera (coconut) fruit oil, decyl glucoside, glycerin, phenoxythanol, potassium sorbate, sodium benzoate, water.

Principal Display Panel

Pura

48 medicated hemmorhoidal wipes

made from biodegradable plant fibers

Cooling and soothing Witch hazel

100% plastic-free flushable wipes

Pura's Pledge

We believe that you shouldn't have to choose between caring for your famile and caring for the environment. That's why we are on a mission to only create products that are good for people and planets.

48 WIPES - 7.7 X 6.3 IN

(195 X 160 MM)

When Using This Product
  • 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
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
Keep Out of the Reach of Children

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)


Structured Label Content

Uses
  • helps relieve the local itching and discomfort associated with hemmorhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas

Purpose

Astringent

Warnings

For external use only

Directions
  • adult: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use upto 6 times daily or after each bowel movement and before applying hemmorhoidal treatments and then discard.
  • children under 12 years of age consult a doctor
  • Flush or dispose of wipe in thrash
  • For best results flush no more than one wipe at a time
Active Ingredient

Witch Hazel 50%

Other Information
  • store at room temperature 20 - 25 ºC (68 - 77ºF)
  • for vaginal care- cleanse the area by gently wiping, patting or blotting. Repeat as needed
  • for use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutesand repeat as needed.
Inactive Ingredients

aloe barbadensis leaf extract, citric acid, cocos nucifera (coconut) fruit oil, decyl glucoside, glycerin, phenoxythanol, potassium sorbate, sodium benzoate, water.

Principal Display Panel

Pura

48 medicated hemmorhoidal wipes

made from biodegradable plant fibers

Cooling and soothing Witch hazel

100% plastic-free flushable wipes

Pura's Pledge

We believe that you shouldn't have to choose between caring for your famile and caring for the environment. That's why we are on a mission to only create products that are good for people and planets.

48 WIPES - 7.7 X 6.3 IN

(195 X 160 MM)

When Using This Product (When using this product)
  • 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
Keep Out of the Reach of Children (Keep out of the reach of children)

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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