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HYDROCORTISONE by Honeywell Safety Products USA, inc

Dosage form: ointment
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Honeywell Safety Products USA, inc
NDC Code: 0498-0800

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.

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

Principal Display Panel

HYDROCORTISONE 
anti-itch cream ointment
Product Information
Product TypeHUMAN OTC DRUGItem 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 Description
1NDC:0498-0800-0325 PACKET in 1 BOX, UNIT-DOSE
10.9 g in 1 PACKET
2NDC:0498-0800-02144 PACKET in 1 BOX, UNIT-DOSE
20.9 g in 1 PACKET
3NDC:0498-0800-011728 PACKET in 1 CARTON
30.9 g in 1 PACKET
4NDC:0498-0800-3220 PACKET in 1 BOX, UNIT-DOSE
40.9 g in 1 PACKET
5NDC:0498-0800-33100 PACKET in 1 BOX, UNIT-DOSE
50.9 g in 1 PACKET
6NDC:0498-0800-3410 PACKET 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 - Honeywell Safety Products USA, inc (079287321)
Registrant - Honeywell Safety Products USA, Inc (079287321)
Establishment
NameAddressID/FEIOperations
Honeywell Safety Products USA, Inc079287321manufacture(0498-0800)

 
Honeywell Safety Products USA, inc

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Medically reviewed on Aug 27, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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