Cortizone 10 Intensive Moisture Creme

Cortizone 10 Intensive Moisture Creme
SPL v3
SPL
SPL Set ID 096a9af3-7e7c-4dae-bc22-44061c60d3c9
Route
TOPICAL
Published
Effective Date 2024-02-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Water Glycerin Petrolatum Jojoba Oil, Randomized Cetyl Alcohol Aloe Vera Leaf Stearyl Alcohol Distearyldimonium Chloride Cetostearyl Alcohol Steareth-2 Steareth-21 Magnesium Ascorbyl Phosphate Chamomile Hydrolyzed Jojoba Esters (acid Form) Alpha-tocopherol Acetate Niacinamide Polysorbate 60 Stearamidopropyl Pg-dimonium Chloride Phosphate Dimethicone Glyceryl Monostearate Hydroxyacetophenone Methyl Gluceth-20 Menthyl Lactate, (-)- Propylene Glycol Ethylhexylglycerin Ppg-12/smdi Copolymer Edetate Disodium Anhydrous Transforming Growth Factor Beta Receptor Type 3

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-01

Description

Cortizone 10 Intensive Moisture Creme Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone 10 Intensive Moisture Creme Drug Facts

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema psoriasispoison 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

Section 42229-5

Cortizone 10 Intensive Moisture Creme

Drug Facts

Warnings

For external use only

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

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.

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

water, glycerin, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, magnesium ascorbyl phosphate, chamomilla recutita (matricaria) flower extract, hydrolyzed jojoba esters, tocopheryl acetate, niacinamide, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, dimethicone, glyceryl stearate, hydroxyacetophenone, methyl gluceth-20, menthyl lactate, propylene glycol, ethylhexylglycerin, PPG-12/SMDI copolymer, disodium EDTA, beta-glucan (357-178)

Principal Display Panel

MAXIMUM STRENGTH

Cortizone 10


INTENSIVE MOISTURE CREME

1% Hydrocortisone


Anti-Itch Creme


Net wt 1 oz (28 g)

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.


Structured Label Content

Use

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:

    eczema psoriasispoison 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

Section 42229-5 (42229-5)

Cortizone 10 Intensive Moisture Creme

Drug Facts

Purpose

Anti-itch

Warnings

For external use only

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

Do Not Use (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.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Inactive Ingredients (Inactive ingredients)

water, glycerin, petrolatum, jojoba esters, cetyl alcohol, aloe barbadensis leaf juice, stearyl alcohol, distearyldimonium chloride, cetearyl alcohol, steareth-2, steareth-21, magnesium ascorbyl phosphate, chamomilla recutita (matricaria) flower extract, hydrolyzed jojoba esters, tocopheryl acetate, niacinamide, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, dimethicone, glyceryl stearate, hydroxyacetophenone, methyl gluceth-20, menthyl lactate, propylene glycol, ethylhexylglycerin, PPG-12/SMDI copolymer, disodium EDTA, beta-glucan (357-178)

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

MAXIMUM STRENGTH

Cortizone 10


INTENSIVE MOISTURE CREME

1% Hydrocortisone


Anti-Itch Creme


Net wt 1 oz (28 g)

When Using This Product (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 (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. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)