RUGBY HYDROSKIN- hydrocortisone cream 
Rugby Laboratories

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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Rugby HydroSKIN 1% Hydrocortizone Cream 1 oz (6995)

Active ingredient                                                                       Purpose

Hydrocortisone 1%....................................................................Anti-itch

Uses for the 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

Warnings

Do not use in the genital area if you have a vaginal discharge. Consult a doctor.
Do not use for the treatment of diaper rash. Consult a doctor.

Avoid contact with the 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 using this product and ask a doctor

Do not use this product and ask a doctor

Keep this and all drugs out of the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

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

Directions

For itching of skin iritation, inflammation, and rashes:

For external anal and genital itching, adults:

Other information

Inactive ingredients

Aloe Vera Gel, Butylated Hydroxytoluene, Cetanol, Liquid Paraffin, Methylparaben, Polyoxyethylene Cetylether, Propylene Glycol, Propylparaben, Purified Water, Sorbitan Monostearate, Stearyl Alcohol

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150  USA

www.rugbylaboratories.com


Made in Korea

HydroSKIN 1% Cream with Aloe
RUGBY HYDROSKIN 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0536-1069
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 LEAF (UNII: ZY81Z83H0X)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
MINERAL OIL (UNII: T5L8T28FGP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-1069-951 in 1 CARTON07/15/2015
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 not finalpart34807/15/2015
Labeler - Rugby Laboratories (079246066)

Revised: 12/2017
Document Id: 5fa240c5-0a1c-45a9-e053-2a91aa0a4ae8
Set id: 41faf3d7-c9fe-4123-9fbe-03d58adea28d
Version: 5
Effective Time: 20171205
 
Rugby Laboratories