The following Structured Product Label (SPL) was submitted to the FDA by Sato Pharmaceutical Co., Ltd. for the product Poli-a (NDC 49873-703). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
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.
Warnings
For external use only
Do not use for the treatment of diaper rash. Consult a doctor.
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)
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.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
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
Other information keep tube tightly closed
Inactive ingredients fragrance, glyceryl monostearate, light mineral oil, white petrolatum, zinc oxide
Active ingredient
Hydrocortisone acetate 1.0%
Purpose Antipruritic (anti-itch)
Carton (Poliacart)
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