HYDROCORTISONE- hydrocortisone lotion 
Mericon Industries

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

Uses

For the temporary relief associated with minor skin irritations, inflammation and rashes due to:

Other uses of this product should be only under the advice and supervision of a doctor.

Warnings

Stop using this product and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days
  • before you begin using any other hydrocortisone product

Do not use this product and ask a doctor

  • if you have a vaginal discharge
  • before treating diaper rash
  • before using on children under 2 years of age

For external anal itching users

  • do not exceed the recommended daily dosage unless directed by a doctor
  • in case of bleeding, consult a doctor promptly
  • do not put this product into the rectum by using fingers or any mechanical device or applicator

Keep this and all drugs out of the reach of children

Directions

For External Anal Itching Users

  • adults: when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly, and gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • children under 12 years of age: consult a doctor

Other Information

Inactive Ingredients

stearic acid, propylene glycol, lanolin alcohol in mineral oil, isopropyl in myristate, cetyl alcohol, mono- and di-glycerides, polysorbate 80, sorbitan monooleate, a scent and purified water preserved with methylparaben and propylparaben.

PRINCIPAL DISPLAY PANEL - 114 g Bottle Label

0394-0859-32

Mericon Industries, Inc.

Hydrocortisone 1%
Lotion

Anti-Itch
Poison Ivy
Poison Oak
Poison Sumac
Hives • Rashes

Net Wt. 4 oz. (114g)

PRINCIPAL DISPLAY PANEL - 114 g Bottle Label
HYDROCORTISONE 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0394-0859
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Hydrocortisone (UNII: WI4X0X7BPJ) (Hydrocortisone - UNII:WI4X0X7BPJ) Hydrocortisone1.14 g  in 114 g
Inactive Ingredients
Ingredient NameStrength
stearic acid (UNII: 4ELV7Z65AP)  
propylene glycol (UNII: 6DC9Q167V3)  
lanolin alcohols (UNII: 884C3FA9HE)  
mineral oil (UNII: T5L8T28FGP)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
cetyl alcohol (UNII: 936JST6JCN)  
polysorbate 80 (UNII: 6OZP39ZG8H)  
sorbitan monooleate (UNII: 06XEA2VD56)  
water (UNII: 059QF0KO0R)  
methylparaben (UNII: A2I8C7HI9T)  
propylparaben (UNII: Z8IX2SC1OH)  
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0394-0859-3212 in 1 BOX06/12/2023
1114 g in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34806/12/2023
Labeler - Mericon Industries (059943670)
Establishment
NameAddressID/FEIBusiness Operations
Mericon Industries059943670MANUFACTURE(0394-0859)

Revised: 6/2023
Document Id: 2be72297-e06d-479b-815d-3c4305765335
Set id: 8f351b04-8f6d-4353-9100-13a8a80d656a
Version: 1
Effective Time: 20230613
 
Mericon Industries