Quality Choice Anti-itch Cream With Aloe

Quality Choice Anti-itch Cream With Aloe
SPL v1
SPL
SPL Set ID 1cbea7cd-03a0-1469-e063-6294a90a7cc1
Route
TOPICAL
Published
Effective Date 2024-06-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Sorbitan Monostearate Aloe Vera Leaf Edetate Disodium Polysorbate 60 Water Cetyl Alcohol Petrolatum Mineral Oil Methylparaben Propylene Glycol Glyceryl Mono And Dipalmitostearate Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-06-13

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Indications and Usage

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to

  • insect bites
  • eczema
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine genital and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor.
Purpose

Anti-Itch

Description

Hydrocortisone 1%

Warnings

For External Use Only

Do not usefor the treatment of diaper rash, consult a doctor.

For external genital itching if you have a vaginal discharge, consult a doctor.

Packaging

Directions

Adults and children 2 years and older

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

  • do not use, consult doctor

For external and anal itching

  • adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or 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 ithcing consult a doctor.
Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product PRC

Active Ingredient

Hydrocortisone 1%

Other Information
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Edatate Disodium, Methylparaben, Mineral Oil, Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60, propylparaban, mono and di glycerides.

When Using This Product
  • Avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Keep Out of the Reach of Children

If swallowed, get medical help or contact a Poison Control Center immediately


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to

  • insect bites
  • eczema
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis
  • external feminine genital and anal itching
  • Other uses of this product should be only under the advice and supervision of a doctor.
Purpose

Anti-Itch

Warnings

For External Use Only

Do not usefor the treatment of diaper rash, consult a doctor.

For external genital itching if you have a vaginal discharge, consult a doctor.

Packaging

Directions

Adults and children 2 years and older

  • apply to affected area not more than 3 to 4 times daily.

Children under 2 years of age

  • do not use, consult doctor

For external and anal itching

  • adults when practical cleanse the affected area with mild soap and warm water and rinse thoroughly or 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 ithcing consult a doctor.
Distributed By

Distributed By CDMA Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Questions: 800-935-2362

Product PRC

Active Ingredient

Hydrocortisone 1%

Other Information (Other information)
  • Store at controlled room temperature 20º-25ºC (68º-77ºF)
Inactive Ingredients

Aloe Vera (Aloe Barbadensis) leaf juice, Cetyl alcohol, Edatate Disodium, Methylparaben, Mineral Oil, Petrolatum, Propylene glycol, Purified Water, Sorbitan Monostearate, Polysorbate 60, propylparaban, mono and di glycerides.

When Using This Product (When using this product)
  • Avoid contact with the eyes
  • do not begin the use of any other hydrocortisone product unless you have consulted a doctor.
  • for external genital, feminine and anal itching do not exceed the recommended daily dosage unless directed by a doctor. In the case of bleeding, stop use, consult a doctor.
  • do not put this product into the rectum by using fingers or any mechanical device or applicator.
Stop Use and Ask A Doctor (Stop use and ask a doctor)
  • Conditions worsen
  • Symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and do not begin use of any other hydrocortisone product unless directed by a doctor.
Keep Out of the Reach of Children (Keep out of the reach of children)

If swallowed, get medical help or contact a Poison Control Center immediately


Advanced Ingredient Data


Raw Label Data

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