Active Ingredient
Hydrocortisone 1%
Cortizone 10 Feminine Itch Relief Cream
FDA Label NDC 41167-0330
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Chattem, Inc. for the product Cortizone 10 Feminine Itch Relief (NDC 41167-0330). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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)
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