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

Purpose

Anti-itch

Description

Cortizone 10 Feminine Itch Relief Drug Facts


Medication Information

Warnings

For external use only

Purpose

Anti-itch

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 

Description

Cortizone 10 Feminine Itch Relief Drug Facts

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)

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

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  

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

Warnings

For external use only

Purpose

Anti-itch

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 

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)

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

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  

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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