CORTISONE CREAM INTENSIVE HEALING- hydrocortisone cream 
TAI GUK PHARM. CO., LTD

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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Cortisone Cream (Intensive Healing)

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

eczema

seborrheic dermatitis

psoriasis
insect bites
poison ivy, oak, sumac
soaps
detergents
cosmetics
jewelry
external genital and anal itching. Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

  • for external use only
  • avoid contact with eyes

Do not use

  • if you have a vaginal discharge
  • for treating diaper rash
  • on children under 2 years of age

Stop using this product and ask a doctor

  • If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • if anal bleeding occurs

When using this product

  • for external anal itching do not exceed the recommended daily dosage unless directed by a doctor, do not begin the use of any other hydrocortisone product unless you have consulted a doctor
  • do not put this product into rectum by using fingers or any mechanical device or applicator

Keep out of reach of children.

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

Before using any medication, read all label directions. Keep this carton. It contains important information.

Directions

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, consult a doctor

For external anal itching



  • adults: when practical, cleanse affected area with mild soap and warm water and rinse thoroughly
  • by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: consult a doctor

Other Information

  • store at 15 0 to 25 0 C (59 0 to 77 0 F)
  • Lot No. and Expiration Date see box or crimp of tube.

Inactive Ingredients

BHA, cetyl alcohol, edetate disodium, glycerin, methylparaben, propylene glycol, propylparaben, purified lanolin, purified water, sodium benzoate, sodium lauryl sulfate, stearic acid, stearyl alcohol, trolamine, white petrolatum, xanthan gum.

Questions? Call toll-free 1-800-645-3867

Image of carton label
Image of tube label


CORTISONE CREAM  INTENSIVE HEALING
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43136-819
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
Product Characteristics
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43136-819-711 in 1 CARTON01/01/201006/30/2021
156 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34801/01/201006/30/2021
Labeler - TAI GUK PHARM. CO., LTD (689060246)

Revised: 6/2021
 
TAI GUK PHARM. CO., LTD