COOLING ITCH RELIEF RITE AID- hydrocortisone 1% spray 
Rite Aid

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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Drug Facts

Active ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

Uses

Temporarily relieves itching associated with minorskin irritation and rashes due to:

• eczema           • poison ivy, oak and sumac         • cosmetics

• psoriasis         • soaps and detergents                  • jewelry

• insect bites     • seborrheic dermatitis

Warnings

For external use only

Flammable: Do not use while smoking or near heat or flame

Do not use

• in or near the eyes •  for diaper rash: ask a doctor

When using this product

• Keep out of eyes. Rinse with water to remove • Use only as directed. • Do not puncture or incinerate. Contents under pressure
• Do not store at temperature above 120F

Ask doctor before use if you are using any other hydrocortisone product

Stop use and ask a doctor if

• condition worsens or does not improve withing 7 days
• symptomspersist more than 7 days or clear up and occur again within a few days

Keep out of reach of the 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: ask a doctor

Inactive ingredients

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

image description

COOLING ITCH RELIEF  RITE AID
hydrocortisone 1% spray
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11822-1223
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)  
ALCOHOL (UNII: 3K9958V90M)  
Water (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11822-1223-385 g in 1 CAN; Type 0: Not a Combination Product02/07/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34802/07/2013
Labeler - Rite Aid (014578892)
Registrant - Product Quest Mfg (927768135)
Establishment
NameAddressID/FEIBusiness Operations
Product Quest Mfg927768135manufacture(11822-1223) , label(11822-1223)

Revised: 6/2018
Document Id: 250fba41-778c-4db7-af40-61be906953f6
Set id: 70baddca-142f-4a29-b484-e60377612f9f
Version: 1
Effective Time: 20180612
 
Rite Aid