Quality Choice Hydrocortisone Cream 1%

Quality Choice Hydrocortisone Cream 1%
SPL v3
SPL
SPL Set ID acc3e2e5-674f-45b3-e053-2a95a90a9f36
Route
TOPICAL
Published
Effective Date 2020-08-19
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-12-12

Description

Hydrocortisone 1%

Purpose

Anti-Itch


Medication Information

Purpose

Anti-Itch

Description

Hydrocortisone 1%

Uses

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

● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

● detergents ● cosmetics ● jewelry ● external feminine genital and anal itching

Other uses of this product should be only under the advice and supervision of a doctor

Section 42229-5

Distributed by: CDMA, Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Product of PRC

Questions: 800-935-2362

This product is not manufactured or distrubuted by Valeant Pharamceuticals North America, Inc. distributor of Cotaid.

Section 50565-1

Keep out of the reach of children.

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

Section 51945-4

Warnings

For external use only

Do not Use:

For the treatment of a diaper rash, consult with doctor

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

Drug Facts

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a 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 itching: consult a doctor.

Active Ingredient

Hydrocortisone 1%

Other Information

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Inactive Ingredients

Cetyl alcohol, Edetate disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, Sorbitan monostearate

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 case of bleeding, stop use and consult a doctor.
  • do not put this product into the rectum by using fingers or any medicated device or applicator.

Stop Using This Product and Ask A Doctor If
  • 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.

Structured Label Content

Uses

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

● eczema ● seborrheic dermatitis ● psoriasis ● insect bites ● poison ivy, oak, sumac ● soaps

● detergents ● cosmetics ● jewelry ● external feminine 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)

Distributed by: CDMA, Inc.

43157 W 9 Mile Rd.

Novi, MI. 48375

www.qualitychoice.com

Product of PRC

Questions: 800-935-2362

This product is not manufactured or distrubuted by Valeant Pharamceuticals North America, Inc. distributor of Cotaid.

Section 50565-1 (50565-1)

Keep out of the reach of children.

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

Section 51945-4 (51945-4)

Purpose

Anti-Itch

Warnings

For external use only

Do not Use:

For the treatment of a diaper rash, consult with doctor

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

Drug Facts (DRUG FACTS)

Directions

Adults and children 2 years of age and older: apply to the affected area not more than 3 to 4 times daily.

Children under 2 years of age: do not use, consult a 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 itching: consult a doctor.

Active Ingredient (Active ingredient)

Hydrocortisone 1%

Other Information (Other information)

● store at controlled room temperature 20°-25°C ( 68 °- 77 °F)

Inactive Ingredients (Inactive ingredients)

Cetyl alcohol, Edetate disodium, Glyceryl monostearate, Methylparaben, Mineral Oil, Polysorbate 60, Propylene glycol, Propylparaben, Purified Water, Petrolatum, Sorbitan monostearate

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 case of bleeding, stop use and consult a doctor.
  • do not put this product into the rectum by using fingers or any medicated device or applicator.

Stop Using This Product and Ask A Doctor If (Stop using this product and ask a doctor if)
  • 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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)