INSTANT COOLING ITCH RELIEF CVS- 1% hydrocortisone spray

Instant Cooling Itch Relief by

Drug Labeling and Warnings

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

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INSTANT COOLING ITCH RELIEF  CVS
1% hydrocortisone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59779-233
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)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59779-233-03	85 g in 1 CAN; Type 0: Not a Combination Product	11/11/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	11/11/2014

Labeler - CVS (062312574)

Registrant - Product Quest Mfg, LLC (927768135)

Establishment
Name	Address	ID/FEI	Business Operations
Product Quest Mfg, LLC		927768135	manufacture(59779-233) , label(59779-233)