GENUINE HYDROCORTISONE - hydrocortisone cream 
Genuine First Aid, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Genuine Hydrocortisone Cream

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.

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


Genuine Hydrocortisone Cream

Maximum Strength

Anti Itch



Active ingredient:

Hydrocortisone Acetate

(equivalent to Hydrocortisone 1%)


Genuine Hydrocortisone Cream - Individual

Genuine Hydrocortisone Cream- Box

GENUINE HYDROCORTISONE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-2903
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52124-2903-10.9 g in 1 PACKET
2NDC:52124-2903-2100 in 1 BOX
20.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/29/2011
Labeler - Genuine First Aid, LLC (619609857)

Revised: 3/2011
Document Id: e83702cb-1a10-4c78-b809-c0341cc507d0
Set id: 597cf1be-50e3-4cdf-b013-1eb72fea667d
Version: 1
Effective Time: 20110329
 
Genuine First Aid, LLC