Poli-a

Poli-a
SPL v8
SPL
SPL Set ID e27a3840-d9de-4bd0-ad75-8a151bd12b83
Route
TOPICAL
Published
Effective Date 2011-12-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Light Mineral Oil Glyceryl Monostearate Petrolatum Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1995-03-19

Description

Uses For the temporary relief of itching associated with minor skin irritations and rashes due to ■eczema    ■insect bites    ■poison ivy    ■poison oak    ■poison sumac ■soaps    ■detergents    ■cosmetic    ■jewelry ■seborrheic determatis    ■psoriasis    ■external anal itching Other uses of this product should be only under the advice and supervision of a doctor.


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to

■eczema    ■insect bites    ■poison ivy    ■poison oak    ■poison sumac

■soaps    ■detergents    ■cosmetic    ■jewelry

■seborrheic determatis    ■psoriasis    ■external anal itching

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



Dosage and Administration

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, consult a doctor



(When used for external anal itching)

■adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. gently dry by patting or blotting with toilet tissue or soft cloth before application of this product

■children under 12 years of age: consult a doctor

Description

Uses For the temporary relief of itching associated with minor skin irritations and rashes due to ■eczema    ■insect bites    ■poison ivy    ■poison oak    ■poison sumac ■soaps    ■detergents    ■cosmetic    ■jewelry ■seborrheic determatis    ■psoriasis    ■external anal itching Other uses of this product should be only under the advice and supervision of a doctor.

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9

Stop use of this or any other hydrocortisone product and ask a doctor if



■condition worsens ■symptoms persist for more than 7 days.



■symptoms clear up and occur again within a few days.

Section 50567-7

When using this product



■avoid contact with the eyes



■do not exceed the recommended daily dosage unless directed by a doctor (for external anal itching)



■consult a doctor promptly in case of bleeding (for external anal itching)



■do not put this product into the rectum by using fingers or any mechanical device or applicator (for external anal itching)

Section 50570-1

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





Section 51727-6

Inactive ingredients  fragrance, glyceryl monostearate, light mineral oil, white petrolatum, zinc oxide

Section 51945-4

Section 55105-1

Purpose    Antipruritic (anti-itch)

Section 55106-9

Active ingredient 

Hydrocortisone acetate 1.0%

Section 60561-8

Other information  keep tube tightly closed


Structured Label Content

Indications and Usage (34067-9)

Uses

For the temporary relief of itching associated with minor skin irritations and rashes due to

■eczema    ■insect bites    ■poison ivy    ■poison oak    ■poison sumac

■soaps    ■detergents    ■cosmetic    ■jewelry

■seborrheic determatis    ■psoriasis    ■external anal itching

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



Dosage and Administration (34068-7)

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, consult a doctor



(When used for external anal itching)

■adults and children 12 years of age and older: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. gently dry by patting or blotting with toilet tissue or soft cloth before application of this product

■children under 12 years of age: consult a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.





Section 50566-9 (50566-9)

Stop use of this or any other hydrocortisone product and ask a doctor if



■condition worsens ■symptoms persist for more than 7 days.



■symptoms clear up and occur again within a few days.

Section 50567-7 (50567-7)

When using this product



■avoid contact with the eyes



■do not exceed the recommended daily dosage unless directed by a doctor (for external anal itching)



■consult a doctor promptly in case of bleeding (for external anal itching)



■do not put this product into the rectum by using fingers or any mechanical device or applicator (for external anal itching)

Section 50570-1 (50570-1)

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





Section 51727-6 (51727-6)

Inactive ingredients  fragrance, glyceryl monostearate, light mineral oil, white petrolatum, zinc oxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Purpose    Antipruritic (anti-itch)

Section 55106-9 (55106-9)

Active ingredient 

Hydrocortisone acetate 1.0%

Section 60561-8 (60561-8)

Other information  keep tube tightly closed


Advanced Ingredient Data


Raw Label Data

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