HYDROCORTISONE ANTI ITCH- hydrocortisone cream 
H E B

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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HEB 1% Hydrocortisone Cream Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children.

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

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: do not use, ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

  • store at 20°-25°C (68°-77°F)

Inactive ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, benzyl alcohol, butylated hydroxytoluene, cetostearyl alcohol, cetyl alcohol, chamomilla recutita (matricaria) flower extract, diazolidinyl urea, dimethicone, distearyldimonium chloride, edetate disodium, glycerin, glyceryl monostearate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, jojoba esters, magnesium ascorbyl phosphate, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, potassium hydroxide, PPG-12/SMDI copolymer, propylparaben, purified water, retinyl palmitate, stearamidopropyl PG-dimonium chloride phosphate, steareth-2, steareth-21, stearyl alcohol, tocopheryl acetate

Questions or comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Cortizone • 10® Intensive Healing Formula Creme

Maximum Strength

1% Hydrocortisone Cream

Anti-Itch Cream

Intensive Healing Formula

Clinically Proven To Moisturize

24 Hours

With Antioxidants & Chamomile. Vitamins A, C & E

1% Hydrocortisone Cream Carton Image 1

1% Hydrocortisone Cream Carton Image 1

1% Hyrdocortisone Cream Carton Image 2

1% Hydrocortisone Cream Carton Image 2

HYDROCORTISONE  ANTI ITCH
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37808-369
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALOE VERA LEAF 
OAT 
BENZYL ALCOHOL 
BUTYLATED HYDROXYTOLUENE 
CETOSTEARYL ALCOHOL 
CETYL ALCOHOL 
CHAMOMILE 
DIAZOLIDINYL UREA 
DIMETHICONE 
DISTEARYLDIMONIUM CHLORIDE 
EDETATE DISODIUM 
GLYCERIN 
GLYCERYL MONOSTEARATE 
HYDROLYZED JOJOBA ESTERS (ACID FORM) 
MAGNESIUM ASCORBYL PHOSPHATE 
MENTHYL LACTATE 
METHYL GLUCETH-20 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 60 
POTASSIUM HYDROXIDE 
PROPYLPARABEN 
WATER 
VITAMIN A PALMITATE 
STEARETH-2 
STEARETH-21 
STEARYL ALCOHOL 
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37808-369-641 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34809/15/2010
Labeler - H E B (007924756)

Revised: 9/2010
Document Id: a1a9fed8-4938-48b5-81f1-d3942d534bb8
Set id: a1a9fed8-4938-48b5-81f1-d3942d534bb8
Version: 1
Effective Time: 20100915
 
H E B