HYDROCORTISONE- hydrocortisone acetate cream

Hydrocortisone by

Drug Labeling and Warnings

Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Maximum strength Anti-itch

Uses

For temporary relief of itching associated with minor skin irritations and rashes due to eczema, seborrheic dermatitis, insect bites, poison ivy, poison oak, poison sumac, sores, detergents, cosmetic and jewelry. Other uses of this product should be only under supervision of a physician.

Warnings

 For external use only.

Do not use:

In eyes. On children under 2 years of age, unless under advice and supervision of a doctor.

If condition persists for more than 7 days.

Keep out of reach of children

If ingested, get medical help or contact a Poison Control Center immediately.

Directions

Adults and Children 2 years and older apply to affected area no more than 4 times daily,

Children under 2: Consult a doctor

Other Information

Store at room temperature

(Do not freeze)

Inactive Ingredients

Propylene glycol, Carbomer, Purified water.

PRINCIPAL DISPLAY PANEL

Genuine Hydrocortisone Cream

Maximum Strength

Anti-Itch

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for
Genuine First Aid

Product Labeling

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-0007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52124-0007-1	0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part348	04/23/2010

Labeler - Genuine First Aid (619609857)