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  5. Label Information: Cortizone 10 Feminine Itch Relief

FDA Label for Cortizone 10 Feminine Itch Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. WHEN USING THIS PRODUCT
    7. STOP USE AND ASK A DOCTOR IF
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. INACTIVE INGREDIENTS
    11. PRINCIPAL DISPLAY PANEL

Cortizone 10 Feminine Itch Relief Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, 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 external feminine itching

■ other uses of this product should only be under the advice and supervision of a doctor


Warnings



For external use only


Do Not Use



■ for the treatment of diaper rash. Consult a doctor.  ■ if you have vaginal discharge. Consult a doctor.  ■ if you are allergic to any ingredient in this product  


When Using This Product



■ avoid contact with eyes  ■ do not use more than directed unless told to do so by a doctor


Stop Use And Ask A Doctor If



■ condition worsens, 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



■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

■ adults and children 12 years of age and older: apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily 

■ children under 12 years of age: ask a doctor 


Inactive Ingredients



water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA


Principal Display Panel



Cortizone 10
FAST ITCH RELIEF
LAST FOR HOURS
FEMININE ITCH
RELIEF
1% Hydrocortisone
Anti-Itch Crème
Net wt 1 oz (28 g)

Cortizone 10FAST ITCH RELIEFLAST FOR HOURSFEMININE ITCHRELIEF1% Hydrocortisone Anti-Itch CrèmeNet wt 1 oz (28 g) - cortizone 10 feminine itch relief 01

Cortizone 10FAST ITCH RELIEFLAST FOR HOURSFEMININE ITCHRELIEF1% Hydrocortisone Anti-Itch CrèmeNet wt 1 oz (28 g) - cortizone 10 feminine itch relief 01


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