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 Type HUMAN OTC DRUG Item Code (Source) NDC:0498-0800
Route of Administration TOPICAL DEA Schedule     
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 GLYCOLS (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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0498-0800-03 25 in 1 BOX, UNIT-DOSE
1 0.9 g in 1 PACKET
2 NDC:0498-0800-02 144 in 1 BOX, UNIT-DOSE
2 0.9 g in 1 PACKET
3 NDC:0498-0800-01 1728 in 1 CARTON
3 0.9 g in 1 PACKET
4 NDC:0498-0800-32 20 in 1 BOX, UNIT-DOSE
4 0.9 g in 1 PACKET
5 NDC:0498-0800-33 100 in 1 BOX, UNIT-DOSE
5 0.9 g in 1 PACKET
6 NDC:0498-0800-34 10 in 1 BOX, UNIT-DOSE
6 0.9 g in 1 PACKET
7 NDC:0498-0800-35 0.9 g in 1 PACKET
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 03/06/2013
Labeler - North Safety Products (019777263)
Establishment
Name Address ID/FEI Business Operations
North Safety Products 019777263 manufacture(0498-0800)
Establishment
Name Address ID/FEI Business Operations
Water-Jel Technologies 155522589 manufacture(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