DCH LABS CORTISONE- hydrocortisone 1% spray

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-itch

INDICATIONS & USAGE

For the temporary relief of itching associated with minor skin irritation and rashes due to

• eczema
• poison ivy, oak, and sumac
• cosmetics
• soaps and detergents
• jewelry
• insect bites

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

WARNINGS

For external use only.

Flammable. Keep away from fire or flame.

Do not use for the treatment of diaper rash. Consult a doctor.

When using this product

• avoid contact with eyes. In case of contact with eyes, flush thoroughly with water
• avoid contact with broken skin
• do not inhale or ingest
• contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120F.

Stop use and ask a doctor if

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

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

DOSAGE & ADMINISTRATION

Adults and children 2 years or older: apply to affected area not more than 3 to 4 times daily

Children under 2 years of age: ask a doctor

To apply to face, spray into palm of hand and gently apply.

INACTIVE INGREDIENT

Alcohol denat., dimethyl isosorbide, glycerin, water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DCH LABS CORTISONE 
hydrocortisone 1% spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-113
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
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
ALCOHOL (UNII: 3K9958V90M)
DIMETHYL ISOSORBIDE (UNII: SA6A6V432S)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-113-03	85 g in 1 CAN; Type 0: Not a Combination Product	01/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2024

Labeler - Derma Care Research Labs (116817470)

Registrant - Derma Care Research Labs (116817470)

Establishment
Name	Address	ID/FEI	Business Operations
Derma Care Research Labs		116817470	manufacture(72839-113)