HYDROCORTISONE- hydrocortisone acetate cream

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by JHK Inc dba American Safety & First Aid. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Hydrocortisone acetate 1%

Purpose

Anti-Itch Cream

Use

Temporarily relieves itching associated with minor skin irritations and rashes due to:

• Eczema
• Insect Bites
• Poison Ivy, Oak or Sumac
• Soaps, Detergents or Cosmetics
• Jewelry

Warnings

For external use only

Do not use

• With any other hydrocortisone product unless you have consulted a doctor
• For the treatment of diaper rash, consult a doctor

Stop use and ask a doctor if

• Condition worsens
• Symptoms persist for more than seven days
• Symptoms clear up and occur again within a few days

Keep out of reach of children

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

Directions

• Adults and children two years and over: apply to affected area not more than three to four times daily
• Children under two years: Do not use

Other Information

• Do not use if packet is torn, cut or opened
• Store at room temperature (do not freeze)
• See packet for Lot Number and expiration date

Inactive ingredient

Cetearyl alcohol, Ceteareth-20, Ethylhexylglycerin/Phenoxyethanol Glycerin, Glycerol fatty acid ester Mineral Oil, Petrolatum, Water

Questions?

1-866-651-3660 Monday-Friday

8:00am-5:00pm EST

PRINCIPAL DISPLAY PANEL - 25 Packet Carton

Product #1014

Hydrocortisone Cream
USP 1%

For the temporary relief of itching
associated with minor skin
irritations and rashes.

25 - Unit Dose Packets

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
hydrocortisone acetate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73598-1014
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE ACETATE	0.9 g  in 0.9 g

Inactive Ingredients
Ingredient Name	Strength
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73598-1014-1	25 in 1 CARTON	02/02/2000
1		1 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	02/02/2000

Labeler - JHK Inc dba American Safety & First Aid (867236309)