Your browser does not support JavaScript! TOPCARE HYDROCORTISONE (HYDROCORTISONE) OINTMENT [TOPCO ASSOCIATES LLC]
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TOPCARE HYDROCORTISONE (hydrocortisone) ointment
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch ointment

Uses

  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • external genital and 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

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When using this product consult a doctor before exceeding recommended dosage

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use any other hydrocortisone product unless you have consulted a doctor.

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

For external anal itching

  • Adults: 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 a soft cloth before application of this product

Children under 12 years of age: consult a doctor

Other information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

QUESTIONS?

1-888-423-0139
topcare@topco.com

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®

MAXIMUM STRENGTH

Hydrocortisone 1%
ANTIPRURITIC (ANTI-ITCH) OINTMENT

NET WT 1 OZ (28.4 g)

QUALITY GUARANTEED

COMPARE TO
CORTIZONE•10®
active ingredient*

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   HYDROCORTISONE
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-018
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Medium-chain triglycerides 
Methylparaben 
Propylparaben 
Petrolatum 
Packaging
#Item CodePackage Description
1NDC:36800-018-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/03/1989
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-018)

Revised: 01/2013
Document Id: 6be8f701-114a-402b-a9a1-67d2daf764b4
Set id: bd3585fa-3b48-49b7-8ad1-749bf1e31ed5
Version: 1
Effective Time: 20130117
 
Topco Associates LLC

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