Cortizone 10 Feminine Itch Relief

Cortizone 10 Feminine Itch Relief
SPL v3
SPL
SPL Set ID c0c0c1fb-43c9-4903-bb3b-f0885619b8cc
Route
TOPICAL
Published
Effective Date 2023-10-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

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

Description

Cortizone 10 Feminine Itch Relief Drug Facts

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Cortizone 10 Feminine Itch 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, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA

Use

 temporarily relieves external feminine itching

 other uses of this product should only be under the advice and supervision of a doctor

Active

Hydrocortisone 1%

Section 42229-5

Cortizone 10

Feminine Itch Relief

Drug Facts

Warnings

For external use only

Directions

■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

  adults and children 12 years of age and older : apply a fingertip amount (approximately 1-inch strip) to affected area not more than 3 to 4 times daily 

children under 12 years of age: ask a doctor 

Do Not Use

■ for the treatment of diaper rash. Consult a doctor.  ■ if you have vaginal discharge. Consult a doctor.  ■ if you are allergic to any ingredient in this product  

Principal Display Panel

Cortizone 10

FAST ITCH RELIEF


LAST FOR HOURS

FEMININE ITCH


RELIEF


1% Hydrocortisone


Anti-Itch 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

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

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, chamomilla recutita (matricaria) flower extract, tocopheryl acetate, magnesium ascorbyl phosphate, retinyl palmitate, hydrolyzed jojoba esters, beta-glucan, glyceryl stearate, menthyl lactate, polysorbate 60, methyl gluceth-20, stearamidopropyl PG-dimonium chloride phosphate, PPG-12/SMDI copolymer, potassium hydroxide, diazolidinyl urea, propylene glycol, benzyl alcohol, methylparaben, BHT, propylparaben, EDTA

Use

 temporarily relieves external feminine itching

 other uses of this product should only be under the advice and supervision of a doctor

Active

Hydrocortisone 1%

Section 42229-5 (42229-5)

Cortizone 10

Feminine Itch Relief

Drug Facts

Purpose

Anti-itch

Warnings

For external use only

Directions

■ when practical, clean the affected area with mild soap and warm water and rinse thoroughly then gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

  adults and children 12 years of age and older : apply a fingertip amount (approximately 1-inch strip) 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)

■ for the treatment of diaper rash. Consult a doctor.  ■ if you have vaginal discharge. Consult a doctor.  ■ if you are allergic to any ingredient in this product  

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cortizone 10

FAST ITCH RELIEF


LAST FOR HOURS

FEMININE ITCH


RELIEF


1% Hydrocortisone


Anti-Itch 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

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

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

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