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Hydro Skin

Rugby Laboratories

Amerisource Bergen Anti-Itch Lotion Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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

Hydro Skin

HYDROCORTISONE LOTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0536-5105
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
Hydrocortisone HYDROCORTISONE 1 g

Inactive Ingredients

Ingredient Name Strength
water
BENZYL ALCOHOL
GLYCERIN
ISOPROPYL PALMITATE
LACTIC ACID
sorbitol

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0536-5105-97 118 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 2012-10-29


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Be sure to consult your doctor before taking any medication!
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