Medication Guide App

Poli-A

Dosage form: ointment
Ingredients: hydrocortisone acetate 1.0g in 100g
Labeler: Sato Pharmaceutical Co., Ltd.
NDC Code: 49873-703

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DRUG FACTS

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

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Active ingredient 
Hydrocortisone acetate 1.0%

Purpose    Antipruritic (anti-itch)

POLI-A 
hydrocortisone acetate ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49873-703
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
hydrocortisone acetate (hydrocortisone) hydrocortisone acetate1.0 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
GLYCERYL MONOSTEARATE 
LIGHT MINERAL OIL 
PETROLATUM 
ZINC OXIDE 
Packaging
#Item CodePackage Description
1NDC:49873-703-011 TUBE in 1 CARTON
120 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34803/19/1995
Labeler - Sato Pharmaceutical Co., Ltd. (690575642)
Establishment
NameAddressID/FEIOperations
Sato Pharmaceutical Co., Ltd.715699133manufacture(49873-703), label(49873-703), pack(49873-703)

Revised: 10/2013
 
Sato Pharmaceutical Co., Ltd.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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