FDA Label for Anti Itch

View Indications, Usage & Precautions

Anti Itch Product Label

The following document was submitted to the FDA by the labeler of this product Meijer Distribution Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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 be only under the advice and supervision of a doctor

Warnings



For external use only


Do Not Use



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

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, aluminum sulfate, calcium acetate, cetearyl alcohol, cetyl alcohol, cholecalciferol, dextrin, glycerin, isopropyl palmitate, light mineral oil, maltodextrin, methylparaben, propylene glycol, propylparaben, purified water, retinyl palmitate, sodium cetearyl sulfate, sodium lauryl sulfate, tocopherol, white petrolatum, white wax, zea mays (corn) oil


Questions Or Comments?



1-800-719-9260


Principal Display Panel



MAXIMUM STRENGTH

Anti-itch cream

#1 DOCTOR RECOMMENDED anti-itch active ingredient

Hydrocortisone 1%

Enriched With Vitamins A, D & E

DRY, ITCHY SKIN | IRRITATION | RASHES | INSECT BITES

Compare to Cortizone•10® Plus

active ingredient

MAXIMUM STRENGTH

anti-itch cream

Hydrocortisone 1%

Enriched With Vitamins A, D & E

DRY, ITCHY SKIN | IRRITATION | RASHES | INSECT BITES

NET WT 1 OZ (28 g)


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