HYDROCORTISONE by Honeywell Safety Products USA, inc

Dosage form: ointment
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Honeywell Safety Products USA, inc
NDC Code: 0498-0800

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.

1% Hydrocortisone Cream

Active ingredient

(In each gram)

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

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

Warnings

For external use only

Ask a doctor before use if

Ask a doctor before use if you are using any other hydrocortisone product

When using the product

avoid contact with eyes
do not begin use of any other hydrocortisone product unless you have consulted a doctor
do not use for the treatment of diaper rash

Stop use and ask a doctor if

condition worsens
condition persists for more than 7 days
condition clears up and recurs 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 2 years and older:

clean the affected area
apply to the area not more than 3 to 4 times daily
children under 2 years of age: consult a doctor

Other information

store at room temperature (do not freeze)

Inactive ingredients

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

Questions or comments?

1-800-430-5490

Principal Display Panel

HYDROCORTISONE
anti-itch cream ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0498-0800
Route of Administration	TOPICAL	DEA Schedule

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

Inactive Ingredients
Ingredient Name	Strength
EDETATE DISODIUM
LIGHT MINERAL OIL
STEARIC ACID
GLYCERYL MONOSTEARATE
POLYETHYLENE GLYCOLS
CETYL ALCOHOL
TROLAMINE
METHYLPARABEN
PROPYLENE GLYCOL
DIAZOLIDINYL UREA
PROPYLPARABEN
GLYCERIN
WATER
CITRIC ACID MONOHYDRATE

Packaging
#	Item Code	Package Description
1	NDC:0498-0800-03	25 PACKET in 1 BOX, UNIT-DOSE
1		0.9 g in 1 PACKET
2	NDC:0498-0800-02	144 PACKET in 1 BOX, UNIT-DOSE
2		0.9 g in 1 PACKET
3	NDC:0498-0800-01	1728 PACKET in 1 CARTON
3		0.9 g in 1 PACKET
4	NDC:0498-0800-32	20 PACKET in 1 BOX, UNIT-DOSE
4		0.9 g in 1 PACKET
5	NDC:0498-0800-33	100 PACKET in 1 BOX, UNIT-DOSE
5		0.9 g in 1 PACKET
6	NDC:0498-0800-34	10 PACKET in 1 BOX, UNIT-DOSE
6		0.9 g in 1 PACKET
7	NDC:0498-0800-35	0.9 g in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	03/06/2013