Your browser does not support JavaScript! HYDROSKIN (HYDROCORTISONE) CREAM [RUGBY LABORATORIES]
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RxNorm Names

HYDROSKIN (hydrocortisone) cream
[Rugby Laboratories]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Warnings

For external use only

Do not use

  • for the treatment of diaper rash. Ask a doctor.
  • in the genital area if you have a vaginal discharge. Ask a doctor.

When using this product

  • avoid contact with the eyes
  • for external anal itching, do not use more than directed. In case of bleeding, consult a doctor promptly 
  • do not insert cream 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

Keep out of reach of children.

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

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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, ask 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 a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

  • store at 15°-30°C (59°-86°F)
  • see box or crimp of tube for lot number and expiration date

Inactive ingredients

emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol solution, Preservative: benzyl alcohol

Questions or comments?

1-800-645-2158

Principal Display Panel

Maximum Strength

Anti-Itch Cream

1% Hydrocortisone Anti-Itch Cream

HydroSkin 1% Cream

HYDROSKIN 
hydrocortisone cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-5108
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
GLYCERIN 
WATER 
ISOPROPYL PALMITATE 
LACTIC ACID 
SORBITOL 
Product Characteristics
ColorWHITE (Off white) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5108-951 in 1 CARTON
128 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart34810/29/2012
Labeler - Rugby Laboratories (191427277)

Revised: 1/2013
 
Rugby Laboratories

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