Cortizone 10 Cream
FDA Label NDC 41167-0039

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 (NDC 41167-0039). 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, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Active Ingredient:

→ Purpose

→ Uses

→ Do Not Use

→ When Using This Product

→ Stop Use And Ask A Doctor If

→ Keep Out Of Reach Of Children.

→ Directions

→ Other Information

→ Inactive Ingredients

→ Principal Display Panel

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

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.

in the genital area if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

in the genital area if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

in the genital area if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

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

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

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

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

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

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

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

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

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

Other Information

contents filled by weight, not volume

contents filled by weight, not volume

contents filled by weight, not volume

contents filled by weight, not volume

contents filled by weight, not volume

Inactive Ingredients

aloe barbadensis leaf juice, avena sativa (oat) kernel extract, cyclopentasiloxane, dimethicone, dimethicone/vinyl dimethicone crosspolymer, disodium EDTA, glycerin, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, isohexadecane, maltodextrin, menthyl lactate, methyl gluceth-20, methylparaben, polysorbate 60, propylparaben, SD Alcohol 40-2 (15%), sodium citrate, water

CHATTEM®