HYDROCORTISONE- anti-itch cream ointment

HYDROCORTISONE by

Drug Labeling and Warnings

HYDROCORTISONE by is a Otc medication manufactured, distributed, or labeled by Water-Jel Technologies. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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
• tamper evident sealed packets
• 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, purified water, stearic acid, trolamine

Questions ?

800-275-3433

info@waterjel.com

www.waterjel.com

Principal Display Panel

INGREDIENTS AND APPEARANCE

HYDROCORTISONE 
anti-itch cream ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	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
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)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	04/30/2010

Labeler - Water-Jel Technologies (155522589)

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