Medicated Wipes
FDA Label NDC 50730-7993

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Triad Group for the product Medicated Wipes (NDC 50730-7993). 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, use, warnings, consult a doctor, do not, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Witch Hazel 50% v/v

Purpose

Astringent

Use

For temporary relief of local discomfort, burning, and irritation associated with hemorrhoids

Warnings

For external use only. Avoid contact with eyes.


Consult A Doctor

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • before exceeding the recommended dosage

Do Not

Put this product into rectum using fingers or any mechanical device or applicator

Otc - Ask Doctor/Pharmacist


Otc - When Using


Otc - Stop Use


Otc - Pregnancy Or Breast Feeding


Keep Out Of Reach Of Children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children
12 years and older		Up to 6 times daily or after
each bowel movement
Children under 12Consult a doctor

  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. Gently apply to the affected area by patting and then discard. Apply to the affected area up to 6 times daily or after each bowel movement.

Other Information

  • Store at room temperature: 15°- 30° C (59° - 86° F)
  • For best results, flush only one wipe at a time

Other Uses

  • for vaginal care - cleanse the area  by gently wiping, patting or blotting with pad and discard. 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.

Inactive Ingredients

Aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, sodium citrate, water

Otc - Questions


Package Information - Label

NDC 50730-7993-1
Compare to Preparation H® active ingredient*

CAREONE®

pre-moistened
MEDICATED WIPES
HEMORRHOIDAL WIPES WITH WITCH HAZEL WITH ALOE

Comforts, Soothes
Cools Irritated Tissue
Flushable

48 WIPES


Distributed by:
American Sales Company
4201 Walden Avenue
Lancaster, NY, 14086

©2010 S and S Brands, Inc,
www.Care1.info

Quality Guaranteed or your money back.

*This product is not manufactured or distributed by Wyeth Consumer Healthcare, owner of the registered trademark PREPARATION H®.




Foil (Mm 08f A1009)

Foil (Mm 08f A1009)

Label (Pl 7993l A1209)

Label (Pl 7993l A1209)

* Please review the disclaimer below.