RUGBY HYDROSKIN- hydrocortisone cream

RUGBY HYDROSKIN by

Drug Labeling and Warnings

RUGBY HYDROSKIN by is a Otc medication manufactured, distributed, or labeled by Rugby Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient                                                                       Purpose

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

PURPOSE

Uses for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to:

• eczema
• seborrheic dermatitis
• psoriasis
• insect bites
• poison ivy, oak, sumac
• soaps
• detergents
• cosmetics
• jewelry
• external genital, feminine and anal itching.

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

WARNINGS

Warnings

• for external use only

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.

• when using this product

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 USE

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
• do not begin use of any other hydrocortisone product unless you have consulted a doctor.
• if rectal bleeding occurs.

DO NOT USE

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

KEEP OUT OF REACH OF CHILDREN

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.

INDICATIONS & USAGE

Directions

For itching of skin iritation, inflammation, and rashes:

• for adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
• children under 2 years of age: do not use, consult a doctor

For external anal and genital itching, adults:

• when practical, clean the affected area with mild soap and warm water and rinse thoroughly.
• gently dry by patting or blotting with toilet tissue or soft cloth before applying
• apply to affected area not more than 3 to 4 times daily
• children under 12 years of age: consult a doctor

STORAGE AND HANDLING

Other information

• store at 20º-25ºC (68º-77ºF)
• Lot No. and Exp. Date: see box or see crimp of tube
• Retain carton for complete product labeling

INACTIVE INGREDIENT

Inactive ingredients

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

DOSAGE & ADMINISTRATION

Distributed by:

Rugby Laboratories

31778 Enterprise Drive

Livonia, MI 48150  USA

www.rugbylaboratories.com

Made in Korea

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

RUGBY HYDROSKIN 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0536-1069
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0536-1069-95	1 in 1 CARTON	07/15/2015
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	07/15/2015

Labeler - Rugby Laboratories (079246066)