HYDROCORTISONE by HF Acquisition Co LLC, DBA HealthFirst HYDROCORTISONE ointment

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by HF Acquisition Co LLC, DBA HealthFirst. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

PURPOSE

Anti-itch cream

DOSAGE & ADMINISTRATION

for the temporary relief of itching associated with minor skin irritations and rashes
other uses of this product should be only under the advice and supervision of a doctor

WARNINGS

For external use only

DO NOT USE

Do not use

for the treatment of diaper rash. Consult a doctor

WHEN USING

When using this product

avoid contact with eyes
do not begin use of any other hydrocortisone product unless you've consulted a doctor

STOP USE

Stop use and ask a doctor if

condition worsens
symptoms persist more than 7 days
condition clears up and occurs again within a few days

KEEP OUT OF REACH OF CHILDREN

Keep out of the reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
children under 2 years; do not use, consult a doctor

OTHER SAFETY INFORMATION

clean the affected area
store at room temperature
do not use any opened or torn packets
you may report a serious adverse reaction to this product to 800-275-3433

INACTIVE INGREDIENT

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, stearic acid, trolamine, water

HOW SUPPLIED

2packs in 1pouch NDC (51662-1284-1)

INDICATIONS & USAGE

Anti-itch ointment

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51662-1284(NDC:59898-800)
Route of Administration	TOPICAL

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

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
LIGHT MINERAL OIL (UNII: N6K5787QVP)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
CETYL ALCOHOL (UNII: 936JST6JCN)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
TROLAMINE (UNII: 9O3K93S3TK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51662-1284-1	2 in 1 POUCH	04/30/2010
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	04/30/2010

Labeler - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Registrant - HF Acquisition Co LLC, DBA HealthFirst (045657305)

Establishment
Name	Address	ID/FEI	Business Operations
HF Acquisition Co LLC, DBA HealthFirst		045657305	repack(51662-1284)