Otc - Active Ingredient
Hydrocortisone 0.5%
Rephresh Cooling
FDA Label NDC 70233-774
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Fleet Laboratories Ltd for the product Rephresh Cooling (NDC 70233-774). 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 otc - active ingredient, otc - purpose, use, warnings, otc - ask doctor/pharmacist, otc - when using, otc - do not use, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
External Analgesic/Anti-Itch
Use
For the temporary relief of external feminine itching
Other uses of this product should be only under the advice and supervision of a doctor
Warnings
Warning(s) For external vaginal use only
Otc - Ask Doctor/Pharmacist
Consult a doctor if you are allergic to any ingredient in this product
Otc - When Using
Avoid contact with eyes
Otc - Do Not Use
Do not use if you have vaginal discharge
Do not use more than directed unless told to do so by a doctor
Otc - Stop Use
Stop use and ask a doctor if condition worsens, symptoms persists for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have consulted a doctor
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
Directions
Adults and children under 12 years of age and older: Apply to affected area not more than 3 to 4 times daily
Children under 12 years of age: Do not use, consult a doctor
When practical, cleanse and dry the affected area before application of this product
Remove safety seal and cap
Dosage & Administration
Pump 3-5 times before first use for proper dispensing
Shake gently before applying
Holding tube 6 inches away from vaginal are and apply using 1 quick, firm spray.
Note: Tube is designed to spray upside down, if needed
Other Safety Information
Keep away from hear or direct sunlight, store at room temperature
Do not use if safety seal is broken or missing
Inactive Ingredient
Water, Propanediol, Propylene Glycol, Pentylene Glycol, Laureth-9, Polysorbate 20, Chamomilla Recutita (Matricaria) Flower Extract, Menthyl Ethylamido Oxalate, Citronellyl Methylcrotonate, Aloe Barbadensis (Aloe Vera) Leaf Juice Powder, Lactic Acid
Otc - Questions
Questions? Call us at 800 833 9532 Monday through Friday 9 to 5 pm ET or visit our website at www rephresh com
Package Label.Principal Display Panel
RepHresh™ Vaginal Anti-Itch Spray
Cooling Relief Spray
#1 Trusted Brand
Gynecologist Recommended
Unscented
0.50 FL OZ (15mL)
0.5% Hydrocortisone
* Please review the disclaimer below.
