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 Type HUMAN OTC DRUG Item Code (Source) NDC:36800-099
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
cetostearyl alcohol (UNII: 2DMT128M1S)  
sodium lauryl sulfate (UNII: 368GB5141J)  
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
chamomile flower oil (UNII: 60F80Z61A9)  
citric acid monohydrate (UNII: 2968PHW8QP)  
corn oil (UNII: 8470G57WFM)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
isopropyl palmitate (UNII: 8CRQ2TH63M)  
maltodextrin (UNII: 7CVR7L4A2D)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
petrolatum (UNII: 4T6H12BN9U)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
vitamin A palmitate (UNII: 1D1K0N0VVC)  
cholecalciferol (UNII: 1C6V77QF41)  
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-099-02 1 in 1 CARTON
1 28.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part348 08/23/1995
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(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