Active Ingredient
Witch hazel 50%
Signature Care Medicated Wipes Hemorrhoidal Wipes With Witch Hazel Cloth
FDA Label NDC 21130-800
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Living Brands Llc for the product Signature Care Medicated Wipes Hemorrhoidal Wipes With Witch Hazel (NDC 21130-800). 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, directions, other information, 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 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
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 topical hemorrhoidal treatments, and then discard
children under 12 years of age: consult a doctor
Other Information
store at room temperature
Inactive Ingredients
2-Bromo-2-Nitropropane-1,3-Diol, Aloe Barbadensis Leaf Juice, Citric Acid, Disodium Cocoamphodiacetate, Glycerin, Iodopropynyl Butylcarbamate, PEG-75 Lanolin, Propylene Glycol, Sodium Citrate, Water
Other Uses
for vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.
for use as a 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 up to 15 minutes and repeat as needed.
For Comments Or Questions Please
DISTRIBUTED BY BETTER LIVING BRANDS LLC
P.O. BOX 99, PLEASANTON, CA 94566-0009
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center right away.
Principal Display Panel - Lid Label
Signature Care
Quality Guaranteed
Compare to the active ingredient in Preparation H(R) Medicated Wipes*
MEDICATED WIPES
HEMORRHOIDAL WIPES WITH WITCH HAZEL
Mild, everyday wipes to ease & lessen irritation
Soothing; Gentle; Soft
Convenient; Easy to use
For hemorrhoidal & vaginal care
WITH ALOE TO SOOTHE
48 MEDICATED WIPES
5 in X 6 in (12.7 cm x 15.2 cm)
2OA9131SLI
2oa9131sli Lid (2oa9131sli)
2oa9131r Flow Wrap (2oa9131r)
* Please review the disclaimer below.
