HYDROCORTISONE - hydrocortisone acetate ointment 
Water-Jel Technologies

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.

----------

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

Warnings

For external use only

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

  • the condition gets worse
  • 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.

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
  • tamper evident sealed packets
  • do not use any opened or torn packets

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

800-275-3433  info@waterjel   www.waterjel.com

Principal Display Panel

Image of pdp
HYDROCORTISONE 
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59898-800
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (HYDROCORTISONE) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
EDETATE DISODIUM 
LIGHT MINERAL OIL 
STEARIC ACID 
GLYCERYL MONOSTEARATE 
POLYETHYLENE GLYCOL 
CETYL ALCOHOL 
TROLAMINE 
METHYLPARABEN 
POLYETHYLENE GLYCOL 
DIAZOLIDINYLUREA 
PROPYLPARABEN 
GLYCERIN 
WATER 
Packaging
#Item CodePackage Description
1NDC:59898-800-0325 in 1 BOX, UNIT-DOSE
10.9 g in 1 PACKET
2NDC:59898-800-02144 in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC:59898-800-011728 in 1 CARTON
30.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2010
Labeler - Water-Jel Technologies (155522589)
Registrant - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture

Revised: 04/2010
Document Id: b36aca39-15b0-49d7-ae6b-e432d1feafe1
Set id: 3d34ae31-265a-46bc-a52d-546ea5bb24b6
Version: 1
Effective Time: 20100430
 
Water-Jel Technologies