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  5. Label Information: Thera Plus Eczema Hydrocortisone Anti Itch

FDA Label for Thera Plus Eczema Hydrocortisone Anti Itch

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. ACTIVE INGREDIENTS
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. DO NOT USE
    7. WHEN USING THIS PRODUCT
    8. STOP USE AND ASK A DOCTOR IF
    9. KEEP OUT OF REACH OF CHILDREN.
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS?
    14. PACKAGE LABELING:

Thera Plus Eczema Hydrocortisone Anti Itch Product Label

The following document was submitted to the FDA by the labeler of this product Fourstar Group Usa, 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 Ingredients



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 under advice and supervision of a doctor

Warnings



For external use only.


Do Not Use



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

When Using This Product



  • avoid contact with 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 persists 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 (1-800-222-1222).


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 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 room temperature 68 °- 77° F (20° - 25°C).

Inactive Ingredients



aloe barbadensis leaf juice, cetyl alcohol, dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate, isohexadecane, maltodextrin, methyl gluceth-20, methylparaben, petrolatum, phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic acid, tocopherol, water, zingiber officinale (ginger) root extract


Questions?



1-800-639-3803Weekdays 9 AM to 4 PM EST


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