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2. Overview
3. Regulation of OTC Drugs
4. OTC Monographs
5. OTC Monographs
Advisory Review Panel 6. OTC Monographs
ANPR 7. OTC Monographs Comments ANPR TFM 8. OTC Monographs Comments Data TFM FM 9. Regulatory History of Hydrocortisone 10. Regulatory History of Hydrocortisone
11. Regulatory History ofHydrocortisone
12. Regulatory History ofHydrocortisone
13. Regulatory History of Hydrocortisone
14. Regulatory History ofHydrocortisone
15. Regulatory History of Hydrocortisone
16. Regulatory History ofHydrocortisone
17. Regulatory History of Hydrocortisone
18. Regulatory History of Hydrocortisone
19. Hydrocortisone Does Not Suppress HPA Axis * Hydrocortisone acetate 7 8 14 10 9 n Ellison et al., 2000 Lucky et al., 1997 Patel et al., 1995 Marten et al., 1980 Munro, 1979 Published Study 0.5 17.7 years 1 28 days 2.5 3 - 10 years 1 28 days 1 14 days 1* Duration of Treatment Hydrocortisone (%) 20. Current Labeling of Hydrocortisone 21. Monograph Labeling:Hydrocortisone Warnings External use only Do not use for the treatment of diaper rash.Consult a doctor. in the genital area if you have a vaginal discharge.Consult adoctor.
Active ingredientPurpose Hydrocortisone (1%)....Anti-itch Drug Facts Drug Facts(continued) When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed bya doctor do not cover treated skin do not use any other hydrocortisone product do not put directly in rectum using fingers or any mechanicaldevice Directions adults and children 2 years of age and older:a pply to affectedarea not more than 3 to 4 times daily. children under 2 years of age:Do not use.Consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occuragain within a few days rectal bleeding occurs 22. Monograph Labeling:Hydrocortisone temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to: eczema poison ivy, oak, sumac insect bites soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis and for external genital or anal itching Stop use and ask a doctor if symptoms persist for more than 7 days or clear up and occur again within a few days apply to affected area not more than 3 to 4 times daily. children under 2 years of age:Do not use.Consult a doctor. Warnings External use only Do not use for the treatment of diaper rash.Consult a doctor. in the genital area if you have a vaginal discharge.Consult adoctor.
Active ingredientPurpose Hydrocortisone (1%)....Anti-itch Drug Facts Drug Facts(continued) When using this product avoid contact with the eyes do not exceed the recommended daily dosage unless directed bya doctor do not cover treated skin do not use any other hydrocortisone product do not put directly in rectum using fingers or any mechanicaldevice Directions adults and children 2 years of age and older:a pply to affectedarea not more than 3 to 4 times daily. children under 2 years of age:Do not use.Consult a doctor. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Stop use and ask a doctor if condition worsens symptoms persist for more than 7 days or clear up and occuragain within a few days rectal bleeding occurs 23. temporarily relieves itching of minor skin irritations, inflammation and rashes symptoms persist for more than 7 days or clear up andoccur again within a few days apply to affected area not more than 3 to 4 times daily children under 2 years of age: do not use, ask a doctor