PREMIER VALUE  HYDROCORTISONE- hydrocortisone cream 
Pharmacy Value Alliance 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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Premier Value®
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

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?

Call 1-866-923-4914

Distributed By: Pharmacy Value Alliance, LLC
407 East Lancaster Avenue, Wayne, PA 19087

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Premier
Value
®

Hydrocortisone
Cream 1%

Intensive Healing Formula†

NET WT 1 oz (28.4 g)
ANTIPRURITIC (ANTI-ITCH)

INDEPENDENTLY TESTED
PV
SATISFACTION GUARANTEED

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
PREMIER VALUE   HYDROCORTISONE
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68016-099
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
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68016-099-021 in 1 CARTON08/23/1995
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 finalpart34808/23/1995
Labeler - Pharmacy Value Alliance LLC (101668460)

Revised: 3/2018
Document Id: 934c7f1b-9cb5-44c0-82c4-c2b85b95af46
Set id: 480bea74-2bf7-4824-a593-f5ac1f24650f
Version: 3
Effective Time: 20180302
 
Pharmacy Value Alliance LLC