HYDROCORTISONE- hydrocortisone ointment 
Taro Pharmaceuticals U.S.A., Inc.

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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Hydrocortisone

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch ointment

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

Fractionated Coconut Oil, Methylparaben, Propylparaben, White Petrolatum

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.

Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Itch and Rash Relief
MAXIMUM STRENGTH

Hydrocortisone 1%
Ointment

Antipruritic (Anti-Itch)
NET WT 1 oz (28.4 g)

Principal Display Panel - 28.4 g Tube Carton
HYDROCORTISONE 
hydrocortisone ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2018
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:51672-2018-21 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 - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2018)

Revised: 1/2020
Document Id: d97e0037-cd87-4bb2-8f28-aa384b685cd6
Set id: f7aecfb4-c194-4554-8d05-4e46005e654b
Version: 2
Effective Time: 20200127
 
Taro Pharmaceuticals U.S.A., Inc.