HYDROCORTISONE - hydrocortisone acetate cream 
Dynarex Corporation

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.

----------

Dynarex Hydrocortisone Cream 1%

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Uses:

For temporary relief of;
  • minor skin irritations
Itching and rashes due to;
  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry

and for external itching of;
  •  genital
  • feminine and
  • anal itching

Warnings:

For external use only

Do not use:

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator

Stop use and ask a physician if:

  • the condition persists or gets worse
  • symptoms clear up and occur again within a few days
  • you are pregnant or breast feeding

Keep out of reach of children

  • If swallowed, get medical help or contact a Poison Control Center right away.

Directions:

Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 or 4 times daily.
Children under 2 years of age
  • Do not use
  • consult a physician
Adults
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after each bowel movement

Other information:

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
  • Avoid excessive heat and humidity

Inactive ingredients:

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

Hydrocortisone 1%

Hydrocortisone

HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:67777-224
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
PROPYLENE GLYCOL 
WATER 
CETETH-20 
CETOSTEARYL ALCOHOL 
CHLOROCRESOL 
EDETATE DISODIUM 
MINERAL OIL 
SODIUM METABISULFITE 
PETROLATUM 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67777-224-0172 in 1 CASE
128.3 g in 1 TUBE
2NDC:67777-224-0812 in 1 CASE
2425 g in 1 JAR
3NDC:67777-224-0212 in 1 CASE
3144 in 1 BOX
30.9 g in 1 PACKET
4NDC:67777-224-031728 in 1 CASE
40.9 g in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/02/2010
Labeler - Dynarex Corporation (008124539)
Registrant - Dynarex Corporation (008124539)

Revised: 1/2012
 
Dynarex Corporation