HYDROCORTISONE- hydrocortisone 1% cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Derma Care Research Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone 1%

PURPOSE

Anti-itch

DOSAGE & ADMINISTRATION

For the temporary relief of itching associated with minor skin irritations and rashes due to eczema, insect bites, and poison oak.

WARNINGS

For external use only.

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

When using this product use only as directed, avoid contact with eyes or mucous membranes.

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days if symptoms clear up and occur again within a few days and do not begin use of any other hydrocortisone product unless you have asked a doctor.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

INDICATIONS & USAGE

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 INGREDIENT

Aloe Barbadensis Leaf Extract, Cetearyl Alcohol, Cetyl Alcohol, Chamomilla Recutita (Matricaria) Flower Extract, Dimethicone, Disodium EDTA, Ethylhexylglycerin, Glycerin Methyl Gluceth-20, Petrolatum, Phenoxyethanol, Polysorbate 60, Potassium Hydroxide, Propylene Glycol, Steareth-2, Steareth-21, Stearyl Alcohol, Tocopheryl Acetate, Water.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone 1% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72839-033
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
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETYL ALCOHOL (UNII: 936JST6JCN)
CHAMOMILE (UNII: FGL3685T2X)
DIMETHICONE 350 (UNII: 2Y53S6ATLU)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
GLYCERIN (UNII: PDC6A3C0OX)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
STEARETH-21 (UNII: 53J3F32P58)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72839-033-01	28 g in 1 TUBE; Type 0: Not a Combination Product	06/14/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	06/14/2019

Labeler - Derma Care Research Labs, LLC (116817470)