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Hydrocortisone by Choice Laboratories

Medically reviewed on February 2, 2018

Dosage form: cream
Ingredients: HYDROCORTISONE ACETATE 1g in 100g
Labeler: Choice Laboratories
NDC Code: 63174-224

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.

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:

Citric acid, Glycerin, Glycerol sterate, Methylparaben, Petrolatum, Polysorbate 80, Propylene Glycol, Propylparaben, Sodium citrate, Titanium dioxide, Water (purified)

Principal Display Panel

Hydrocortisone Cream 1%




HYDROCORTISONE 
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63174-224
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
CITRIC ACID MONOHYDRATE 
GLYCERIN 
GLYCERYL MONOSTEARATE 
METHYLPARABEN 
PETROLATUM 
POLYSORBATE 80 
PROPYLENE GLYCOL 
SODIUM CITRATE 
TITANIUM DIOXIDE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63174-224-0172 TUBE (TUBE) in 1 CASE
128.3 g in 1 TUBE
2NDC:63174-224-0812 JAR (JAR) in 1 CASE
2425 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34802/02/2010
Labeler - Choice Laboratories (650070394)
Establishment
NameAddressID/FEIOperations
Choice Laboratories650070394manufacture

 
Choice Laboratories

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Further information

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

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