Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 0559c16d-7422-407f-a4cc-401902a26686
Route
TOPICAL
Published
Effective Date 2014-07-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Cetostearyl Alcohol Edetate Disodium Glyceryl Stearate Se Methylparaben Mineral Oil Petrolatum Polysorbate 60 Propylene Glycol Propylparaben Sorbitan Monostearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-06-15

Description

Hydrocortisone 1%

Purpose

Anti-itch


Medication Information

Purpose

Anti-itch

Description

Hydrocortisone 1%

Uses

■ for temporary relief of itching associated with minor skin irritations and rashes due to: ■ eczema  ■ seborrheic dermatitis ■ psoriasis ■insect bites ■ poison ivy, oak, sumac ■ soaps ■ detergents ■ cosmetics ■ jewelry ■  temporarily relieves external anal and genital itching   ■ other uses of this product should be under the advice and supervision of a doctor

Warnings

For external use only

Directions

for itching of skin irritation 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 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 vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information

■ store at 68-77F (20 to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Cetearyl Alcohol, Disodium EDTA, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Water

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

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not beginuse of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed occurs

Keep Out of Reach of Children

If swallowed, get medical help or contact a Poison Control Center right away


Structured Label Content

Uses

■ for temporary relief of itching associated with minor skin irritations and rashes due to: ■ eczema  ■ seborrheic dermatitis ■ psoriasis ■insect bites ■ poison ivy, oak, sumac ■ soaps ■ detergents ■ cosmetics ■ jewelry ■  temporarily relieves external anal and genital itching   ■ other uses of this product should be under the advice and supervision of a doctor

Purpose

Anti-itch

Warnings

For external use only

Directions

for itching of skin irritation 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 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 vaginal discharge. Consult a doctor ■ for the treatment of diaper rash. Consult a doctor

Package Label

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)

■ store at 68-77F (20 to 25C) ■ see carton or tube crimp for lot number and expiration date

Inactive Ingredients

Cetearyl Alcohol, Disodium EDTA, Glyceryl Stearate, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Sorbitan Stearate, Water

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)

■ the condition worsens, symptoms persist for more than 7 days or clear up and occur again wihin a few days, and do not beginuse of any other hydrocortisone product unless you have asked a doctor ■ rectal bleed 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


Advanced Ingredient Data


Raw Label Data

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