Cortizone 10 Overnight Creme

Cortizone 10 Overnight Creme
SPL v2
SPL
SPL Set ID ef2eda7e-d6a8-47e3-9d80-6074af6773dc
Route
TOPICAL
Published
Effective Date 2023-11-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Cortizone   10   Overnight Relief Drug Facts

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch


Medication Information

Purpose

Hydrocortisone 1%...........................................................................................................................................Anti-itch

Description

Cortizone   10   Overnight Relief Drug Facts

In

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 jojoba esters, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, glyceryl stearate, menthyl lactate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, methylparaben, fragrance

Use

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

Section 42229-5

Cortizone   10   Overnight Relief

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.

Principal Display Panel

Cortizone 10

Overnight Crème

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

In

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 jojoba esters, propylene glycol, polysorbate 60, stearamidopropyl PG-dimonium chloride phosphate, glyceryl stearate, menthyl lactate, EDTA, PPG-12/SMDI copolymer, potassium hydroxide, methylparaben, fragrance

Use

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

Section 42229-5 (42229-5)

Cortizone   10   Overnight Relief

Drug Facts

Purpose

Hydrocortisone 1%...........................................................................................................................................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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cortizone 10

Overnight Crème

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.


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Raw Label Data

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