Active Ingredient
Witch Hazel 50%
Witch Hazel Cloth
FDA Label NDC 56194-550
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Giant Eagle for the product Witch Hazel (NDC 56194-550). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, keep out of the reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
* Please review the disclaimer below.
