HYDROCORTISONE ACETATE  ANTIPRURITIC (ANTI-ITCH)- hydrocortisone acetate cream 
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 1% Cream

Drug Facts

Active ingredient

Hydrocortisone acetate (equivalent to 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

cetostearyl alcohol, propylene glycol, purified water, sodium lauryl sulfate, 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 Carton

Itch and Rash Relief

Hydrocortisone 1%
Cream
Hydrocortisone Acetate
Antipruritic (Anti-Itch)

MAXIMUM STRENGTH

NET WT 1 oz (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Carton
HYDROCORTISONE ACETATE   ANTIPRURITIC (ANTI-ITCH)
hydrocortisone acetate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2069
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone Acetate (UNII: 3X7931PO74) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
cetostearyl alcohol (UNII: 2DMT128M1S)  
propylene glycol (UNII: 6DC9Q167V3)  
water (UNII: 059QF0KO0R)  
sodium lauryl sulfate (UNII: 368GB5141J)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51672-2069-21 in 1 CARTON06/01/2001
128.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:51672-2069-9454 g in 1 JAR; Type 0: Not a Combination Product06/01/2001
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34806/01/2001
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2069)

Revised: 3/2023
Document Id: fadbd97a-7096-4c78-b019-a03ab2ca2925
Set id: 9f0b09e7-6cfd-4fd6-8631-67799edf4e08
Version: 5
Effective Time: 20230310
 
Taro Pharmaceuticals U.S.A., Inc.