HYDROCORTISONE CREAM WITH ALOE- hydrocortisone cream 
Rugby Laboratories

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Rugby Hydrocortisone Cream 1% with Aloe

Active Ingredient

Hydrocortisone 1%

Purpose

Anti-Itch

Uses

For temporary relief of itching 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.

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) immediately.

Warnings

For External Anal Itching Users:

Before using any medication, read all label directions. Keep this carton as it contains important information

Do Not Use

Stop using this product and ask a doctor if

When using this product

Directions

Adults and children 2 years and older

Children under 2 years of age

For External and anal itching

by patting or blotting with toilet tissue or a soft cloth before application of this product.

Inactive Ingredients

Aloe barbadensis leaf juice, Cetyl alcohol, Edetate Disodium, Methylparaben, Mineral Oil, Mono and di glycerides, petrolatum, Polysorbate 60, Propylene glycol, propylparaben, purified water, sorbitan monostearate.

Other Information

Other Information

Distributed By:

Rugby Laboratories®

Indianapolis, IN 46268

www.majorpharmaceuticals.com

1-800-616-2471

This product is not manufactured or distributed by Chattem, Inc. owner of the registered trademark Cortizone 10®

Package Label

371172 Rugby Hydrocortisone Cream with Aloe 112823 CDER

HYDROCORTISONE CREAM WITH ALOE 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1407
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
GLYCERYL MONO AND DIPALMITOSTEARATE (UNII: KC98RO82HJ)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PETROLATUM (UNII: 4T6H12BN9U)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
MINERAL OIL (UNII: T5L8T28FGP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1407-951 in 1 BOX03/08/2024
128 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01703/08/2024
Labeler - Rugby Laboratories (079246066)
Registrant - Trifecta Pharmaceuticals USA LLC (079424163)

Revised: 3/2024
Document Id: 132982ea-cce7-687c-e063-6294a90a4632
Set id: 132982ea-cce6-687c-e063-6294a90a4632
Version: 1
Effective Time: 20240308
 
Rugby Laboratories