REPHRESH COOLING- hydrocortisone spray

Rephresh Cooling by

Drug Labeling and Warnings

Rephresh Cooling by is a Otc medication manufactured, distributed, or labeled by Church & Dwight Co., Inc., FLEET LABORATORIES LTD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone 0.5%

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

Do not use if you have vaginal discharge

ASK DOCTOR/PHARMACIST

Consult a doctor if you are allergic to any ingredient in this product

WHEN USING

When using this product

Avoid contact with eyes

DO NOT USE

Do not use more than directed unless told to do so by a doctor

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

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

QUESTIONS

Questions? Call us at 800 833 9532 Monday through Friday 9 to 5 pm ET or visit our website at www rephresh com

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

INGREDIENTS AND APPEARANCE

REPHRESH COOLING 
hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10237-774
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	500 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
CITRONELLYL METHYLCROTONATE (UNII: K61O222P3D)
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
LACTIC ACID (UNII: 33X04XA5AT)
POLIDOCANOL (UNII: 0AWH8BFG9A)
PROPANEDIOL (UNII: 5965N8W85T)
MENTHYL ETHYLENE GLYCOL CARBONATE, (-)- (UNII: 4K3514B1GT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
POLYSORBATE 20 (UNII: 7T1F30V5YH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10237-774-15	1 in 1 CARTON	06/01/2018
1		15 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/01/2018

Labeler - Church & Dwight Co., Inc. (001211952)

Registrant - Church & Dwight Co., Inc. (001211952)

Establishment
Name	Address	ID/FEI	Business Operations
FLEET LABORATORIES LTD		217269489	manufacture(10237-774)