TOPCARE  HYDROCORTISONE INTENSIVE HEALING FORMULA- hydrocortisone cream 
Topco Associates LLC

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.

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TopCare®
Hydrocortisone Intensive Healing Formula

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

Uses

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:

Children under 2 years of age: do not use. Consult a doctor

For external anal itching:

Children under 12 years of age: consult a doctor

Other information

Inactive ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

QUESTIONS?

1-888-423-0139

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

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®

MAXIMUM STRENGTH

Hydrocortisone Cream 1%
Intensive Healing Formula
ANTIPRURITIC (ANTI-ITCH)

NET WT 1 OZ (28.4 g)

QUALITY
GUARANTEED

COMPARE TO CORTIZONE•10®
INTENSIVE HEALING FORMULA*
active ingredient

Principal Display Panel - 28.4 g Tube Carton
TOPCARE   HYDROCORTISONE INTENSIVE HEALING FORMULA
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-099
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (Hydrocortisone) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
cetostearyl alcohol 
sodium lauryl sulfate 
sodium cetostearyl sulfate 
chamomile flower oil 
citric acid monohydrate 
corn oil 
glycerin 
glyceryl monostearate 
isopropyl palmitate 
maltodextrin 
methylparaben 
mineral oil 
paraffin 
petrolatum 
propylene glycol 
propylparaben 
water 
stearyl alcohol 
vitamin A palmitate 
cholecalciferol 
.alpha.-tocopherol acetate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-099-021 in 1 CARTON
128.4 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34808/23/1995
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-099)

Revised: 1/2013
Document Id: cc4257fd-c315-41d9-b709-f32da2ce7f23
Set id: 7daafc44-e2a4-4f1b-bfca-3309a8e9a920
Version: 1
Effective Time: 20130108
 
Topco Associates LLC