FDA Label for Cortizone 10 Overnight Itch Relief
View Indications, Usage & Precautions
Cortizone 10 Overnight 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 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 only be under the 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 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
■ rectal bleeding occurs
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center 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: 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 a 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
Inactive Ingredients
water, glycerin, dimethicone, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, beta-glucan, melatonin, methyl gluceth-20, hydroxyacetophenone, ethylhexylglycerin, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, hydrolyzed collagen, hydrolyzed elastin, hydrolyzed jojoba esters, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, glyceryl stearate, menthyl lactate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, methylparaben, fragrance
Principal Display Panel
OVERNIGHT
ITCH RELIEF
with Lavender Scent
MAXIMUM STRENGTH
Cortizone 10
1% Hydrocortisone Anti-itch Crème
Net wt 1 oz (28 g)
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