Quality Choice®

Quality Choice®
SPL v1
SPL
SPL Set ID 489c554f-efd8-4606-8d17-82c1d58ae08b
Route
TOPICAL
Published
Effective Date 2013-03-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Aloe Vera Whole 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 1995-08-23

Description

Drug Facts

Purpose

Anti-itch cream


Medication Information

Purpose

Anti-itch cream

Description

Drug Facts

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
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7

When using this product consult a doctor before exceeding recommended dosage

Warnings

For external use only

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

Do Not Use
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Questions?

Call 248-449-9300

Active Ingredient

Hydrocortisone 1%

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).

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

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.
Ask A Doctor Before Use If You Have
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton

QC

QUALITY

CHOICE®

Maximum Strength

Hydrocortisone Cream 1%

Intensive Healing Formula

Antipruritic (Anti-Itch)

With Antioxidants & Chamomile

1 OZ NET WT (28.4g)


Structured Label Content

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
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50567-7 (50567-7)

When using this product consult a doctor before exceeding recommended dosage

Purpose

Anti-itch cream

Warnings

For external use only

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

Do Not Use (Do not use)
  • in the eyes
  • by putting this product into the rectum by using fingers or any mechanical device or applicator
Questions?

Call 248-449-9300

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (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 (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).

For External Anal Itching (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

Stop Use and Ask A Doctor If (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.
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • a vaginal discharge
  • rectal bleeding
  • diaper rash
Principal Display Panel 28.4 G Tube Carton (PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton)

QC

QUALITY

CHOICE®

Maximum Strength

Hydrocortisone Cream 1%

Intensive Healing Formula

Antipruritic (Anti-Itch)

With Antioxidants & Chamomile

1 OZ NET WT (28.4g)


Advanced Ingredient Data


Raw Label Data

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