0498-0800: 1% Hydrocortisone Cream

Drug Labeling and Warnings

Drug Details [pdf]

HYDROCORTISONE- anti-itch cream ointment 
Honeywell Safety Products USA, inc

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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0498-0800: 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

Ask a doctor before use if

Ask a doctor before use if you are using any other hydrocortisone product

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

  • condition worsens
  • 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

  • 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 (do not freeze)

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 or comments?

1-800-430-5490

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hydrocortisone

HYDROCORTISONE 
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0498-0800
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 0498-0800-0325 in 1 BOX, UNIT-DOSE03/06/201310/15/2019
10.9 g in 1 PACKET; Type 0: Not a Combination Product
2NDC: 0498-0800-02144 in 1 BOX, UNIT-DOSE03/06/201310/15/2019
20.9 g in 1 PACKET; Type 0: Not a Combination Product
3NDC: 0498-0800-011728 in 1 CARTON03/06/201310/15/2019
30.9 g in 1 PACKET; Type 0: Not a Combination Product
4NDC: 0498-0800-3220 in 1 BOX, UNIT-DOSE03/06/201310/15/2019
40.9 g in 1 PACKET; Type 0: Not a Combination Product
5NDC: 0498-0800-33100 in 1 BOX, UNIT-DOSE03/06/201310/15/2019
50.9 g in 1 PACKET; Type 0: Not a Combination Product
6NDC: 0498-0800-350.9 g in 1 PACKET; Type 0: Not a Combination Product03/06/201310/15/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other03/06/201310/15/2019
Labeler - Honeywell Safety Products USA, inc (118768815)
Registrant - Honeywell Safety Products USA, Inc (118768815)

Revised: 1/2024
Document Id: 0ec9b004-ecf8-99f2-e063-6394a90a6931
Set id: 51c4d717-c6c6-454d-af37-3145dffdba96
Version: 11
Effective Time: 20240111