FDA Label for Preparation H Soothing Relief Cooling
View Indications, Usage & Precautions
Preparation H Soothing Relief Cooling 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.
Active Ingredients
Witch hazel 20%
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▪ Warning – avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F.▪ Warning – use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use And Ask A Doctor If
▪ bleeding occurs▪ condition worsens or does not improve within 7 days
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
▪ Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad. Gently dry by patting or blotting with toilet tissue or a soft cloth before applying the spray.▪ apply externally to the affected area up to 6 times daily or after each bowel movement▪ children under 12 years of age: consult a doctor▪ shake well before using▪ hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
Other Information
▪ store at 20-25°C (68-77°F)
Inactive Ingredients
aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate
Questions?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepH or 1-800-997-7374
Additional Information
No Touch Spray
Do not use if sleeve band around cap is broken or missing
Dist. By: GSK Consumer Healthcare
Warren, NJ 07059
Trademarks owned or licensed by GSK
©2021 GSK or licensor
PAA172637 (Front Carton)
Principal Display Panel
NDC 0573-2889-01
PREPARATION H
NEW!
soothing
RELIEF
cooling spray
HEMORRHOIDAL SPRAY
with ALOE
Quickly Soothes and Cools Discomfort
Relieves Itching, Burning and Irritation
Gentle for Daily Use
NET WT 2.7 OZ (77 g)
* Please review the disclaimer below.