POLI-A- hydrocortisone acetate ointment 
Sato Pharmaceutical Co., Ltd.

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Poli-A

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

POLI-A 
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-703
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE ACETATE (UNII: 3X7931PO74) (HYDROCORTISONE - UNII:WI4X0X7BPJ) HYDROCORTISONE ACETATE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
LIGHT MINERAL OIL (UNII: N6K5787QVP)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PETROLATUM (UNII: 4T6H12BN9U)  
ZINC OXIDE (UNII: SOI2LOH54Z)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49873-703-011 in 1 CARTON03/19/1995
120 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/19/1995
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIBusiness Operations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-703) , label(49873-703) , pack(49873-703)

Revised: 11/2023
Document Id: 0b404611-4b3b-500a-e063-6394a90a62b3
Set id: e27a3840-d9de-4bd0-ad75-8a151bd12b83
Version: 8
Effective Time: 20231128
 
Sato Pharmaceutical Co., Ltd.