INSTANT COOLING ITCH RELIEF CVS- 1% hydrocortisone spray 
CVS

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.

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Active ingredient

Hydrocortisone 1.0%

Purpose

Anti-itch

Uses

For the temporary relief of itching associated with
minor skin irritation and rashes due to: • eczema • poison ivy,
oak and sumac • cosmetics • jewelry • soaps and detergents
• insect bites. Other uses of this product should be only under
the advice and supervision of a doctor.

Warnings

​For external use only.

Flammable:Keep away from fire or flame

Avoid contact with the eyes. If condition worsens, or if
symptoms persist for more than 7 days or clear up and occur
again within a few days, stop use of this product and do not
begin use of any other hydrocortisone product unless you have
consulted a doctor. Do not use for the treatment of diaper rash.
Consult a doctor.
Do not puncture or incinerate. Contents under pressure. Do not
store at temperatures above 120˚F

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• adults and children 2 years of age and older:
apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor

Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water.

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INSTANT COOLING ITCH RELIEF  CVS
1% hydrocortisone spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-233
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLOXAMER 188 (UNII: LQA7B6G8JG)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59779-233-0385 g in 1 CAN; Type 0: Not a Combination Product11/11/2014
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34811/11/2014
Labeler - CVS (062312574)
Registrant - Product Quest Mfg, LLC (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg, LLC927768135manufacture(59779-233) , label(59779-233)

Revised: 6/2018
Document Id: 7bb2cdb8-f9a9-4eb8-ba77-fdb49fbe30cf
Set id: 592dbfb2-868a-4bfc-bf55-608da46395d4
Version: 4
Effective Time: 20180619
 
CVS