FDA Label for Medicated Wipes
View Indications, Usage & Precautions
- ACTIVE INGREDIENT
- PURPOSE
- USE
- WARNINGS
- CONSULT A DOCTOR
- DO NOT
- OTC - ASK DOCTOR/PHARMACIST
- OTC - WHEN USING
- OTC - STOP USE
- OTC - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- OTHER USES
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- PACKAGE INFORMATION - PEEL AWAY LABEL
- PACKAGE INFORMATION - SLEEVE
Medicated Wipes Product Label
The following document was submitted to the FDA by the labeler of this product Mckesson. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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
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
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
* Please review the disclaimer below.