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SAFEWAY

SAFEWAY INC.
Taro Pharmaceuticals U.S.A., Inc.

SAFEWAY Hydrocortisone Plus 12 Moisturizers


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Hydrocortisone 1%

Purpose

Anti-itch cream

SAFEWAY Uses

  • temporary relief of itching associated with minor skin irritations and rashes due to
    • eczema
    • insect bites
    • poison ivy, poison oak, or poison sumac
    • soaps
    • detergents
    • cosmetics
    • jewelry
    • seborrheic dermatitis
    • psoriasis
    • 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

  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator

Ask a doctor before use if you have

  • a vaginal discharge
  • rectal bleeding
  • diaper rash

When using this product consult a doctor before exceeding recommended dosage.

Stop use and ask a doctor if

  • condition gets worse
  • condition persists for more than 7 days
  • condition clears up and occurs again within a few days. Do not begin to use 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

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 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: consult a doctor.

SAFEWAY Other information

  • To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
  • store at room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate)

DISTRIBUTED BY SAFEWAY INC.
P.O. BOX 99
PLEASANTON, CA 94566-0009

1-888-SAFEWAY

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

Maximum Strength

NDC 21130-063-02

Compare to the active
ingredient in Cortizone
●10® Plus and Cortaid ®
Intensive Therapy*

Hydrocortisone 1% Cream Plus 12 Moisturizers

Antipruritic (Anti-Itch)
● Itch and Rash Relief ● Enriched With Vitamins A, D & E

NET WT 1 OZ (28.4 g)

SAFEWAY

SAFEWAY

SAFEWAY

Hydrocortisone CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:21130-063
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
CETOSTEARYL ALCOHOL
SODIUM LAURYL SULFATE
SODIUM CETOSTEARYL SULFATE
CHAMOMILE FLOWER OIL
CITRIC ACID MONOHYDRATE
CORN OIL
GLYCERIN
GLYCERYL MONOSTEARATE
ISOPROPYL PALMITATE
maltodextrin
METHYLPARABEN
Mineral Oil
PARAFFIN
petrolatum
propylene glycol
PROPYLPARABEN
water
stearyl alcohol
VITAMIN A PALMITATE
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 28.4 in 1 TUBE
2 NDC:21130-063-02 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part348 1989-10-03


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Be sure to consult your doctor before taking any medication!
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