REPHRESH COOLING- hydrocortisone spray 
Fleet Laboratories LTD

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

RepHresh Spray

Hydrocortisone 0.5%

External Analgesic/Anti-Itch

For the temporary relief of external feminine itching

Other uses of this product should be only under the advice and supervision of a doctor

Warning(s) For external vaginal use only

Do not use

If you have vaginal discharge

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

When using this product

Avoid contact with eyes

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

Stop use and ask a doctor if condition worsens, symptoms persistfor 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

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

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 information

Keep away from hear or direct sunlight, store at room temperature

Do not use if safety seal is broken or missing

Inactive Ingredients

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

SPRAYS UPSIDE DOWN

RepHresh™ Vaginal Anti-Itch Spray

Cooling Relief Spray

#1 Trusted Brand

Gynecologist Recommended

Unscented

0.50 FL OZ (15mL)

0.5% Hydrocortisone

RepHresh Spray

REPHRESH COOLING 
hydrocortisone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70233-744
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE500 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
PROPANEDIOL (UNII: 5965N8W85T)  
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)  
MENTHYL ETHYLENE GLYCOL CARBONATE, (-)- (UNII: 4K3514B1GT)  
CITRONELLYL METHYLCROTONATE (UNII: K61O222P3D)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
MATRICARIA RECUTITA FLOWERING TOP (UNII: 3VNC7T6Z02)  
LACTIC ACID (UNII: 33X04XA5AT)  
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POLIDOCANOL (UNII: 0AWH8BFG9A)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70233-744-151 in 1 CARTON06/01/201806/07/2018
115 g in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/01/201806/07/2018
Labeler - Fleet Laboratories LTD (217269489)
Registrant - Church & Dwight Co., Inc. (001211952)
Establishment
NameAddressID/FEIBusiness Operations
FLEET LABORATORIES LTD217269489manufacture(70233-744)

Revised: 6/2018
 
Fleet Laboratories LTD