SPL v1
SPL
SPL Set ID 3d27f041-c554-4139-87b5-709537785f22
Route
TOPICAL
Published
Effective Date 2018-05-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1.02 g)
Inactive Ingredients
Water Glycerin Cetostearyl Alcohol Cetyl Palmitate Polyoxyl 20 Cetostearyl Ether Petrolatum Isopropyl Myristate Aloe Vera Leaf Benzyl Alcohol Isostearyl Neopentanoate Peg-40 Stearate Edetate Disodium Shea Butter Methylparaben Propylparaben Chamomile Sodium Citrate Vitamin A Palmitate Cholecalciferol .alpha.-tocopherol Acetate, D- Magnesium Ascorbyl Phosphate Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-03-25

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes and inflammation due to excema.

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

Label

Warnings

For external use only.

Directions

adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.

children under 2 years of age: ask a doctor.

Do Not Use

Do not use for the treatment of diaper rash.  Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

glycerin, methylparaben, propylparaben, petrolatum, cetearyl alcohol, cetyl palmitate, isostearyl neopentanoate, isopropyl myristate, PEG-40 stearate, ceteareth 20, benzyl alcohol, aloe, dimethicone, vitamin A, vitamin D, vitamin E, chamomile extract, sodium citrate, magnesium ascorbyl phosphate (vitamin C), shea butter, EDTA, water

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

Uses

Temporarily relieves the itching and discomfort associated with minor skin irritations, rashes and inflammation due to excema.

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

Label

Purpose

Anti-Itch

Warnings

For external use only.

Directions

adults and children 2 years of age or older: apply to affected area not more than 3 to 4 times daily.

children under 2 years of age: ask a doctor.

Do Not Use (Do not use)

Do not use for the treatment of diaper rash.  Consult a doctor.

Active Ingredient

Hydrocortisone 1%

Inactive Ingredients

glycerin, methylparaben, propylparaben, petrolatum, cetearyl alcohol, cetyl palmitate, isostearyl neopentanoate, isopropyl myristate, PEG-40 stearate, ceteareth 20, benzyl alcohol, aloe, dimethicone, vitamin A, vitamin D, vitamin E, chamomile extract, sodium citrate, magnesium ascorbyl phosphate (vitamin C), shea butter, EDTA, water

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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