Label: POLI-A- hydrocortisone acetate ointment
- NDC Code(s): 49873-703-01
- Packager: Sato Pharmaceutical Co., Ltd.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 28, 2023
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INDICATIONS & 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.
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WARNINGS
Warnings
For external use onlyWhen 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) -
DOSAGE & 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 - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- ACTIVE INGREDIENT
- PURPOSE
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
POLI-A
hydrocortisone acetate ointmentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49873-703 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE 1 g in 100 g Inactive Ingredients Ingredient Name Strength LIGHT MINERAL OIL (UNII: N6K5787QVP) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PETROLATUM (UNII: 4T6H12BN9U) ZINC OXIDE (UNII: SOI2LOH54Z) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49873-703-01 1 in 1 CARTON 03/19/1995 1 20 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M017 03/19/1995 Labeler - Sato Pharmaceutical Co., Ltd. (690575642) Establishment Name Address ID/FEI Business Operations Sato Pharmaceutical Co., Ltd. 715699133 manufacture(49873-703) , label(49873-703) , pack(49873-703)
