FDA Label for Preparation H For Women
View Indications, Usage & Precautions
Preparation H For Women Product Label
The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. 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.
Otc - Active Ingredient
Active ingredient
Witch hazel 20%
Otc - Purpose
Purpose
Astringent
Indications & Usage
Uses
• helps relieve the local itching and discomfort associated with hemorrhoids• temporary relief of irritation and burning• aids in protecting irritated anorectal areas
Warnings
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Dosage & Administration
Directions
• open the lid on the top of the wipes pouch• grab the top wipe at the edge of the center fold and pull out of pouch• close lid after each use to retain moisture• adults: 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
Storage And Handling
Other information
• store at 20-25°C (68-77°F)• for best results, flush only one or two wipes at a time
Inactive Ingredient
Inactive ingredients
aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, diazolidinyl urea, dipropylene glycol, DMDM hydantoin, edetate disodium, fragrance, glycerin, methylisothiazolinone, methylparaben, PEG-75 shea butter glycerides, phenoxyethanol, polysorbate 20, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E acetate
Otc - Questions
Questions or comments?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374
For most recent product information,
visit www.preparationh.com
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 new 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.
Principal Display Panel
NDC 0573-0559-10
PREPARATION H®
MEDICATED HEMORRHOIDAL WIPES
WITH WITCH HAZEL
FOR Women
FLUSHABLE & SEPTIC SAFE
infused with refreshing
CUCUMBER, SOOTHING ALOE,
VITAMIN E, SHEA BUTTER & CHAMOMILE
PreparationH® Medicated Wipes are made with advanced technology, have been scientifically tested to be flushable and are safe for well-maintained sewer and septic systems*. They are made with 100% plant-based materials and are free from chemical binders. *Not recommended for use with basement pump systems. Flush only one wipe at a time.
PAA113382 Front Carton
* Please review the disclaimer below.
