HYDROCORTISONE - hydrocortisone acetate ointment 
North Safety Products

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.

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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

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.

Directions

Other information

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

1-800-430-4110

Principal Display Panel

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HYDROCORTISONE 
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0498-0800
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 
CITRIC ACID MONOHYDRATE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0498-0800-0325 in 1 BOX, UNIT-DOSE
10.9 g in 1 PACKET
2NDC:0498-0800-02144 in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC:0498-0800-011728 in 1 CARTON
30.9 g in 1 PACKET
4NDC:0498-0800-3220 in 1 BOX, UNIT-DOSE
40.9 g in 1 PACKET
5NDC:0498-0800-33100 in 1 BOX, UNIT-DOSE
50.9 g in 1 PACKET
6NDC:0498-0800-3410 in 1 BOX, UNIT-DOSE
60.9 g in 1 PACKET
7NDC:0498-0800-350.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/06/2013
Labeler - North Safety Products (019777263)
Establishment
NameAddressID/FEIBusiness Operations
North Safety Products019777263manufacture(0498-0800)
Establishment
NameAddressID/FEIBusiness Operations
Water-Jel Technologies155522589manufacture(0498-0800)

Revised: 3/2013
Document Id: f4076d5e-97d0-4823-b190-8039fc0dd853
Set id: 51c4d717-c6c6-454d-af37-3145dffdba96
Version: 2
Effective Time: 20130324
 
North Safety Products