TOPCARE  HYDROCORTISONE PLUS 12 MOISTURIZERS- 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 Plus 12 Moisturizers

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

  • 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

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
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%
Plus 12 Moisturizers

ANTIPRURITIC (ANTI-ITCH) CREAM

NET WT 1 OZ (28.4 g)

QUALITY
GUARANTEED

COMPARE TO
CORTIZONE•10® PLUS
active ingredient*

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   HYDROCORTISONE PLUS 12 MOISTURIZERS
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-051
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:36800-051-181 in 1 CARTON
128.4 g in 1 TUBE
2NDC:36800-051-061 in 1 CARTON
242.6 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(36800-051)

Revised: 1/2013
Document Id: 1189d6d6-b691-4bc4-81fb-a43e00dd6106
Set id: c40e8e1d-d6d7-4880-99d3-011b97a5e4f3
Version: 1
Effective Time: 20130117
 
Topco Associates LLC