FREDS HYDROCORTISONE  WITH ALOE- hydrocortisone cream 
FRED'S, 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.

----------

Fred's Hydrocortisone Cream 1%
with Aloe

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 powder, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, citric acid, glycerin, glyceryl monostearate, methylparaben, mineral oil, paraffin wax, propylparaben, purified water, sodium lauryl sulfate, stearyl alcohol

Questions?

Call 1-866-923-4914

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

fred's
Pharmacy

NDC 55315-181-56

Compare to the
Active Ingredient in
Cortizone•10®*

MAXIMUM STRENGTH

Hydrocortisone
Cream 1%
Antipruritic (Anti-Itch)
Itch and Rash Relief

With Healing Aloe

NET WT 1 oz (28.4g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
FREDS HYDROCORTISONE   WITH ALOE
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-181
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
cetostearyl alcohol (UNII: 2DMT128M1S)  
sodium lauryl sulfate (UNII: 368GB5141J)  
sodium cetostearyl sulfate (UNII: 7ZBS06BH4B)  
citric acid monohydrate (UNII: 2968PHW8QP)  
glycerin (UNII: PDC6A3C0OX)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
mineral oil (UNII: T5L8T28FGP)  
paraffin (UNII: I9O0E3H2ZE)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55315-181-561 in 1 CARTON11/15/2018
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 FINALpart34811/15/2018
Labeler - FRED'S, INC. (005866116)

Revised: 11/2018
Document Id: f6f6ccf6-8b2a-4bd5-81ea-55aea3958c07
Set id: 076503bf-8238-4739-bb1c-c385e72f8a96
Version: 1
Effective Time: 20181127
 
FRED'S, INC.