Cortizone 10 Sensitive Skin Creme

Cortizone 10 Sensitive Skin Creme
SPL v3
SPL
SPL Set ID b139917c-00bb-4cb3-995d-a6d2f2c295c6
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 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (100000 Mpa.s At 1.5%) Cetyl Alcohol Glyceryl Monostearate Isohexadecane Methyl Gluceth-20 Oat .alpha.-tocopherol Acetate Magnesium Ascorbyl Phosphate Aloe Vera Leaf Chamomile Shea Butter Ginger Indian Frankincense Levomenol Maltodextrin Ethylhexylglycerin Pentylene Glycol Phenoxyethanol Edetate Disodium Anhydrous Dipropylene Glycol 4-tert-butylcyclohexanol Benzoic Acid Polysorbate 60 Sodium Citrate Citric Acid Monohydrate

Identifiers & Packaging

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

Description

Cortizone 10 Sensitive Skin Anti-itch Creme Drug Facts

Purpose

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


Medication Information

Purpose

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

Description

Cortizone 10 Sensitive Skin Anti-itch Creme Drug Facts

In

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

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

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

Section 42229-5

Cortizone 10

Sensitive Skin Anti-itch Creme

Drug Facts

Warnings

For external use only

Directions

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: do not use, ask a doctor

Do Not Use

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

Principal Display Panel

Cortizone 10

Sensitive Skin Crème

Net
wt 2 oz (56 g)

When Using This Product

avoid contact with the 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, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, cetyl alcohol, dextrin, glyceryl stearate, isohexadecane, methyl gluceth-20, avena sativa (oat) kernel extract, tocopheryl acetate, magnesium ascorbyl phosphate, aloe barbadensis leaf juice, chamomilla recutita (matricaria) flower extract, butyrospermum parkii (shea) butter extract, zingiber officinale (ginger) root extract, boswellia serrata gum, bisabolol, maltodextrin, ethylhexylglycerin, pentylene glycol, phenoxyethanol, disodium EDTA, dipropylene glycol, 4-t-butylcyclohexanol, benzoic acid, polysorbate 60, sodium citrate, citric acid 

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

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

Section 42229-5 (42229-5)

Cortizone 10

Sensitive Skin Anti-itch Creme

Drug Facts

Purpose

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

Warnings

For external use only

Directions

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: do not use, ask a doctor

Do Not Use (Do not use)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Cortizone 10

Sensitive Skin Crème

Net
wt 2 oz (56 g)

When Using This Product (When using this product)

avoid contact with the 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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