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  5. Label Information: Vitacilina Anti Itch Hydrocortisone

FDA Label for Vitacilina Anti Itch Hydrocortisone

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENT (IN EACH GRAM)
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. IF PREGNANT OR BREAST-FEEDING,
    10. KEEP OUT OF REACH OF CHILDREN.
    11. DIRECTIONS
    12. OTHER INFORMATION
    13. INACTIVE INGREDIENTS
    14. PACKAGE LABELING:

Vitacilina Anti Itch Hydrocortisone Product Label

The following document was submitted to the FDA by the labeler of this product Taisho Pharmaceutical California 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.

Drug Facts




Active Ingredient (In Each Gram)



Hydrocortisone 1%


Purpose



Antipruritic (anti-itch)


Uses



  • for the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry
  • and for external anal and genital itching.

Warnings



For external use only.

Avoid contact with eyes


Do Not Use



  • if you have a vaginal discharge. Consult a doctor.

When Using This Product



  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop Use And Ask A Doctor If



  • condition worsens
  • bleeding occurs
  • symptoms persist for more than 7 days or clear up and occurs again within a few days.

If Pregnant Or Breast-Feeding,



ask a health professional before use.


Keep Out Of Reach Of Children.



If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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:consult a doctor
      For external anal and genital itching:
      Adults and children 12 years of age and older:
    • when practical, cleanse the affected area with mild soap or warm water and rinse thoroughly by patting or blotting with an appropriate cleansing pad
    • gently dy by patting or blotting with toilet tissue or a soft cloth before appliction of this product
    • apply to affected area not more than 3 to 4 times daily
    • children under 12 years of age:consult a doctor

Other Information



  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident:DO NOT USE IF SEAL ON TUBE IS BROKEN OR MISSING.

Inactive Ingredients



  • aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Package Labeling:



Label - Label

Label - Label


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