OTC Medication Information: Witch Hazel

WITCH HAZEL- witch hazel cloth
Giant Eagle

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Active Ingredient

Witch Hazel 50%

Purpose

Astringent

Uses

  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporary relief of irritation and burning
  • Aids in protecting irritated anorectal areas

Warnings

For external use only.

When using this product

  • Do not exceed the recommendeed 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).

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 up to 6 times daily or after each bowel movement and before applying hemorrhoidal treatments, and then discard.
  • Children under 12 years of age: consult a doctor.
  • Flush or dispose of wipe in trash.
  • *For best results, flush no more than one wipe at a time.

Other information

  • Store at room temperature 20 — 25°C (68 — 77°F).
  • 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 minutes and repeat as needed.

Inactive Ingredients

Alcohol, Aloe, Citric Acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.

Principal Display Panel

giant eagle

MEDICATED

HEMORRHOIDAL WIPES

COMPARE TO PREPARATION H MEDICATED WIPES

COOLS • SOOTHES • COMFORTS • CONVENIENT • EASY TO USE

FLUSHABLE MILD EVERYDAY WIPES with witch hazel and aloe

48 WIPES • 6 in x 5 in (15.2cm x 12.7cm)

box
(click image for full-size original)
WITCH HAZEL
medicated hemorrhoidal wipes cloth
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:56194-500
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
WITCH HAZEL (WITCH HAZEL) WITCH HAZEL 50 g in 100
Inactive Ingredients
Ingredient Name Strength
POTASSIUM SORBATE
WATER
GLYCERIN
SODIUM BENZOATE
PROPYLENE GLYCOL
CITRIC ACID MONOHYDRATE
ALOE
ALCOHOL
DECYL GLUCOSIDE
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:56194-500-01 48 CLOTH in 1 POUCH None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part346 10/07/2021
Labeler — Giant Eagle (929989007)

Revised: 01/2023 Giant Eagle

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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