Active ingredient

Hydrocortisone acetate (equivalent to Hydrocortisone 1%)

Purpose

Anti-itch cream

Uses

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

for the treatment of diaper rash. Consult a doctor

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 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 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 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 ingredients

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

Questions ?

800-275-3433

info@waterjel.com

www.waterjel.com

Principal Display Panel

HYUD

HYDROCORTISONE
anti-itch cream ointment

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

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

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

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:59898-800-03	25 in 1 BOX, UNIT-DOSE	04/30/2010
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product
2	NDC:59898-800-02	144 in 1 BOX, UNIT-DOSE	04/30/2010
2		0.9 g in 1 PACKET; Type 0: Not a Combination Product
3	NDC:59898-800-01	1728 in 1 CARTON	04/30/2010
3		0.9 g in 1 PACKET; Type 0: Not a Combination Product
4	NDC:59898-800-36	0.9 g in 1 PACKET; Type 0: Not a Combination Product	04/30/2010
5	NDC:59898-800-32	28 g in 1 TUBE; Type 0: Not a Combination Product	04/30/2010

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

Labeler - Water-Jel Technologies (155522589)

Name	Address	ID/FEI	Business Operations
Establishment
Water-Jel Technologies		155522589	manufacture(59898-800)

1% Hydrocortisone Cream