HYDROCORTISONE - hydrocortisone acetate cream 
Genuine First Aid

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 Maximum Strength Anti-Itch

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.


Genuine Hydrocortisone Cream

Maximum Strength

Anti-Itch

Net Wt 0.9g (1/32 oz)

Manufactured in CHINA for
Genuine First Aid

Product Labeling

Genuine Hydrocortisone Cream

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52124-0007
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:52124-0007-10.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34804/23/2010
Labeler - Genuine First Aid (619609857)

Revised: 12/2011
Document Id: 9e4b519d-9710-474a-95bb-d7aa44c6aaf3
Set id: 555ae674-f1fa-4334-81c0-0085cdff1b9a
Version: 14
Effective Time: 20111201
 
Genuine First Aid