TOPCARE  HYDROCORTISONE- hydrocortisone ointment 
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

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

Warnings

For external use only

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.

When using this product

  • avoid contact with eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

fractionated coconut oil, methylparaben, propylparaben, white petrolatum

Questions?

Call 1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

NDC 36800-018-02

TopCare
health

MAXIMUM STRENGTH

• OUR PHARMACISTS
RECOMMEND •

Hydrocortisone Ointment 1%

ANTIPRURITIC (ANTI-ITCH)
Ointment

NET WT 1 OZ (28.4 g)

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 AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Medium-chain triglycerides (UNII: C9H2L21V7U)  
Methylparaben (UNII: A2I8C7HI9T)  
Propylparaben (UNII: Z8IX2SC1OH)  
Petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-018-021 in 1 CARTON10/03/1989
128.4 g in 1 TUBE; Type 0: Not a Combination Product
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: 4/2019
Document Id: 833484f8-7155-45d6-8744-0d91927a0d89
Set id: bd3585fa-3b48-49b7-8ad1-749bf1e31ed5
Version: 2
Effective Time: 20190404
 
Topco Associates LLC