Cortizone 10 Ultra Soothing Itch Relief Cream
FDA Label NDC 41167-0029

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 Ultra Soothing Itch Relief (NDC 41167-0029). 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 ingredients, 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.

Active Ingredients

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

for the temporary relief of 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 only 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, cetearyl alcohol, glycerin, petrolatum, mineral oil, isopropyl palmitate, sodium lauryl sulfate, beeswax, sodium cetearyl sulfate, methylparaben, tocopheryl acetate, propylparaben, propylene glycol, cetyl alcohol, aluminum sulfate, calcium acetate, dextrin, zea mays (corn) oil, cholecalciferol, retinyl palmitate, aloe barbadensis leaf juice, maltodextrin

Principal Display Panel

MAXIMUM STRENGTH
Cortizone 10
ULTRA SOOTHING
ITCH RELIEF
CREAM
1% Hydrocortisone
Anti-Itch Cream
Net wt 1 oz (28 g)

Maximum Strengthcortizone 10ultra Soothingitch Relief Cream 1% Hydrocortisoneanti-itch Creamnet Wt 1 Oz (28 G) (Cortizone 10 Ultra Soothing Itch Relief Cream 01)

Maximum Strengthcortizone 10ultra Soothingitch Relief Cream 1% Hydrocortisoneanti-itch Creamnet Wt 1 Oz (28 G) (Cortizone 10 Ultra Soothing Itch Relief Cream 01)

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