COOLING ITCH RELIEF RITE AID- hydrocortisone 1% spray

Cooling Itch Relief by

Drug Labeling and Warnings

Cooling Itch Relief by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Product Quest Mfg. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

PURPOSE

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

COOLING ITCH RELIEF  RITE AID
hydrocortisone 1% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-1223
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	Hydrocortisone	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-1223-3	85 g in 1 CAN; Type 0: Not a Combination Product	02/07/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	02/07/2013

Labeler - Rite Aid (014578892)

Registrant - Product Quest Mfg (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg		927768135	manufacture(11822-1223) , label(11822-1223)