Hydrocortisone by J&A Digital Inc. HYDROCORTISONE cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by J&A Digital Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

• for the temporary relief of itching associated with minor irritations and rashes
• other uses of this product should be only under the advice and superivision of a doctor.

Warnings

For external use only.

Do not use

for the treatment of diaper rash. Consult a doctor.

Stop use and ask a doctor if

• condition worsens of lasts more than 7 days, or clears up and occurs again within a few days.
• you begin use of any other hydrocortisone product
• bleeding occurs

Keep out of reach of children.

If swallowed 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.

Inactive ingredients

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glycerol fatty acid ester, Mineral Oil, Petrolatum, Phenoxyethanol, Water

Package Labeling:

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82942-1003
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82942-1003-1	0.9 g in 1 PACKET; Type 0: Not a Combination Product	05/08/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	05/08/2023

Labeler - J&A Digital Inc. (040268672)