Genuine Hydrocortisone: Package Insert and Label Information

GENUINE HYDROCORTISONE — hydrocortisone acetate 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.

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 hydrocortisone cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52124-2903 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE 1 g in 100 g

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL WATER

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:52124-2903-1 0.9 g in 1 PACKET None 2 NDC:52124-2903-2 100 PACKET (PACKET) in 1 BOX contains a PACKET 2 0.9 g in 1 PACKET This package is contained within the BOX (52124-2903-2)

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)

Revised: 03/2011 Genuine First Aid, LLC