Your browser does not support JavaScript! HYDRO SKIN (HYDROCORTISONE) LOTION [RUGBY LABORATORIES]
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HYDRO SKIN (hydrocortisone) lotion
[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  

  • for temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewelry
  • seborrheic dermatitis
  • soaps
  • external genital and anal itching
  • other uses of this product should be only 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.
  • for external genital itching if you have a vaginal discharge. Ask a doctor.

When using this product

  • avoid contact with the eyes
  • do not begin use of any other hydrocortisone product unless you have asked a doctor
  • for external anal itching 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

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. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Keep out of reach of children.

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

Directions

shake well before use

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 itching:

  • adults: when practical, cleanse 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 application of this product.
  • children under 12 years of age with external anal itching: ask a doctor

Inactive ingredients

benzyll alcohol, emulsifying wax, glycerin, isopropyl palmitate, lactic acid, purified water, sorbitol 70% solution

Questions or comments?

1-800-645-2158

Package/Label Principal Display Panel

Rugby Laboratories

Maximum Strength

Anti-Itch Lotion

hydrocortisone 1%

Hydro Skin 1% Lotion

HYDRO SKIN 
hydrocortisone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0536-5105
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HYDROCORTISONE (HYDROCORTISONE) HYDROCORTISONE1 g  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
BENZYL ALCOHOL 
GLYCERIN 
ISOPROPYL PALMITATE 
LACTIC ACID 
SORBITOL 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0536-5105-97118 mL in 1 BOTTLE
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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