Medicated Wipes
FDA Label NDC 49348-559

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Mckesson for the product Medicated Wipes (NDC 49348-559). 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

  • 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.
  • Children under 12 years of age: consult a doctor.

Other Information

Store at room temperature: 15°- 30° C (59° - 86° F)

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, purified water, sodium citrate

Otc - Questions


Package Information - Peel Away Label

Sunmark TM

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*
NDC 49348-559-08

pre-moistened
medicated wipes

for hemorrhoidal and vaginal care

Witch Hazel, 50%

FOUR TIMES LARGER THAN MEDICATED PADS

48 FLUSHABLE MEDICATED WIPES
5.6 X 6.0 IN (14.3 X 15.2 cm)

Distributed by McKesson
One Post Street, San Francisco, CA 94104
Money Back Guarantee

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

Peel and  Reseal
LIFT HERE

Tear off and discard strip to begin use
Rev. A



Label (Pl 7903l O 2)

Label (Pl 7903l O 2)




Package Information - Sleeve

Sunmark TM

COMPARE TO PREPARATION H® ACTIVE INGREDIENTS*

NDC 49348-559-08

pre-moistened
medicated wipes

For hemorrhoidal and vaginal care

Contains Aloe
Witch Hazel, 50%

FOUR TIMES LARGER THAN MEDICATED PADS

48 FLUSHABLE MEDICATED WIPES
5.6 X 6.0 IN (14.3 X 15.2 cm)


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

Another Quality Product
Distributed by McKesson
One Post Street, San Francisco, CA 94104

Money Back Guarantee
Please visit us
at www.sunmarkbrand.com


Sleeve (Pl 7903c 0 3)

Sleeve (Pl 7903c 0 3)


* Please review the disclaimer below.