Cortizone 10 Anti-itch Lotion for Diabetics Skin

Manufacturer
Chattem, Inc.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:23:20

Label at a glance#

ProductCortizone 10 Anti-itch for Diabetics Skin
Active ingredientHYDROCORTISONE
Label structure8 sections

Indications and uses

temporarily relieves the itching and discomfort associated with minor skin irritations and rashes other uses of this product should only be under the advice and supervision of a doctor

Dosage and administration

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Cotizone 10® Maximum Strength Anti-Itch Lotion for Diabetics' Skin

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves the itching and discomfort associated with minor skin irritations and rashes
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • 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

OTC - STOP USE SECTION

  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, dimethicone, petrolatum, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, ishexadecane, methyl gluceth-20, aloe barbadensis leaf extract, avena sativa (oat) kernel extract, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shae) butter extract, boswellia serrata gum, zingiber officinale (ginger) root extract, bisabolol, magnesium ascorbyl phosphate, tocopheryl acetate, malodextrin, ethylhexylglycerin, dehydroacetic acid, polysorbate 60, phenoxyethanol, disodium EDTA, dipropylene glycol, benzoic acid, pentylene glycol, 4-t-butylcyclohexanol, sodium citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cortizone 10®
MAXIMUM STRENGTH
anti-itch lotion for
Diabetics' Skin
fast, lasting relief
to soothe dry, irritated skin
1% Hydrocortisone
Net wt 3.4 oz (96 g)

Cortizone 10® MAXIMUM STRENGTH anti-itch lotion for Diabetics' Skin fast, lasting relief to soothe dry, irritated skin 1% Hydrocortisone Net wt 3.4 oz (96 g)Cortizone 10® MAXIMUM STRENGTH anti-itch lotion for Diabetics' Skin fast, lasting relief to soothe dry, irritated skin 1% Hydrocortisone Net wt 3.4 oz (96 g)

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJ2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ2
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
4-TERT-BUTYLCYCLOHEXANOLINACTIVE INGREDIENTK0H1405S9C2
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X2
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIM2
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCN2
CHAMOMILEINACTIVE INGREDIENTFGL3685T2X2
DEHYDROACETIC ACIDINACTIVE INGREDIENT2KAG279R6R2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
DIPROPYLENE GLYCOLINACTIVE INGREDIENTE107L85C402
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K2
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3P2
GINGERINACTIVE INGREDIENTC5529G5JPQ2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE42
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%)INACTIVE INGREDIENT86FQE96TZ42
ICODEXTRININACTIVE INGREDIENT2NX48Z0A9G2
INDIAN FRANKINCENSEINACTIVE INGREDIENT4PW41QCO2M2
ISOHEXADECANEINACTIVE INGREDIENT918X1OUF1E2
LEVOMENOLINACTIVE INGREDIENT24WE03BX2T2
MAGNESIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT0R822556M52
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2D2
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P2
OATINACTIVE INGREDIENTZ6J799EAJK2
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
SHEANUT OILINACTIVE INGREDIENTO88E196QRF2
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41167-034241167-0342-0

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 286 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, CHEWABLE / ORAL292 mgExact identifier — unii candidate
15 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / SOFT TISSUE1 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMLIQUID / ORAL2 mg/1mlExact identifier — unii candidate
23 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / INTRAVENOUS0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMAEROSOL, FOAM / TOPICAL1 mgExact identifier — unii candidate
23 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNSUSPENSION / TOPICAL2.01 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLOTION / TOPICAL3990 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRADERMAL1.6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KOINTMENT / TOPICAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
75 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DTABLET, COATED / ORAL5.6 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / TOPICAL2.5 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE / ORAL13.75 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS225 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXDROPS / ORAL300 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / VAGINAL200 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, FILM COATED / ORALNAExact identifier — unii candidate
20 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, DELAYED RELEASE / ORAL6 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY, METERED / NASAL13 mgExact identifier — unii candidate
75 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNCREAM / TOPICAL1280 mgExact identifier — unii candidate
20 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / TOPICAL82 mgExact identifier — unii candidate
20 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
DEHYDROACETIC ACIDDEHYDROACETIC ACID2KAG279R6RLOTION / TOPICAL1 mgExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, CHEWABLE / ORAL1 mgExact identifier — unii candidate
77 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCONCENTRATE / ORAL20 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY / RESPIRATORY (INHALATION)0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPONGE / TOPICAL2 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
ICODEXTRINICODEXTRIN2NX48Z0A9GCREAM / TOPICAL0.03 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL23 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS19 mgExact identifier — unii candidate
77 equally ranked IID candidates
MALTODEXTRINMALTODEXTRIN7CVR7L4A2DPASTE / ORAL1050 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXLIQUID / ORAL2400 mgExact identifier — unii candidate
75 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4SUSPENSION / AURICULAR (OTIC)0.5 %w/vExact identifier — unii candidate
21 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CAPSULE, EXTENDED RELEASE / ORAL32.4 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYRUP / ORAL40 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZOIC ACIDBENZOIC ACID8SKN0B0MIMTABLET, COATED / ORALNAExact identifier — unii candidate
23 equally ranked IID candidates
CETYL ALCOHOLCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
bcbd2ebf-9af0-46e4-92ff-cc9f990508ecc0dccf64-44fd-4cbf-a9cd-50b3150ee2052025-01-15WarningsExact identifier
spl set id: c0dccf64-44fd-4cbf-a9cd-50b3150ee205

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.