GENUINE HYDROCORTISONE- hydrocortisone cream

Genuine Hydrocortisone by

Drug Labeling and Warnings

Genuine Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Genuine First Aid, LLC. 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.

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.

Keep out of reach of children

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

SPL UNCLASSIFIED SECTION

GFA Production Xiamen Co., Ltd
No. 20 Huli Industrial Park, Meixi Road,
Tong'an, Xiamen, Fujian, China 361100

Wellkang Ltd t/a Wellkang Tech Consulting
Suite B, 29 Harley Street
LONDON W1G 9QR, England, United Kingdom

Copyright (c) 2010 GFA Production Xiamen Co., Ltd

All rights reserved

PRINCIPAL DISPLAY PANEL

Genuine Hydrocortisone Cream

Maximum Strength

Anti Itch

Active ingredient:

Hydrocortisone Acetate

(equivalent to Hydrocortisone 1%)

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GENUINE HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52124-2903
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: 52124-2903-1	0.9 g in 1 PACKET
2	NDC: 52124-2903-2	100 in 1 BOX
2		0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/29/2011

Labeler - Genuine First Aid, LLC (619609857)