FDA Label for Rephresh Cooling
View Indications, Usage & Precautions
Rephresh Cooling Product Label
The following document was submitted to the FDA by the labeler of this product Fleet Laboratories Ltd. 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
Hydrocortisone 0.5%
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
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