Your browser does not support JavaScript! HYDROCORTISONE (ANTI-ITCH CREAM) OINTMENT [WATER-JEL TECHNOLOGIES]
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HYDROCORTISONE (anti-itch cream) ointment
[Water-Jel Technologies]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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

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HYDROCORTISONE  
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem 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 GLYCOLS 
CETYL ALCOHOL 
TROLAMINE 
METHYLPARABEN 
PROPYLENE GLYCOL 
DIAZOLIDINYL UREA 
PROPYLPARABEN 
GLYCERIN 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
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
4NDC:59898-800-360.9 g in 1 PACKET
5NDC:59898-800-3228 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34804/30/2010
Labeler - Water-Jel Technologies (155522589)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(59898-800)

Revised: 3/2013
 
Water-Jel Technologies

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