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

Purpose

Anti-Itch

Description

Hydrocortisone 1%


Medication Information

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

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

Purpose

Anti-Itch

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.

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

Description

Hydrocortisone 1%

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

Drug Facts

Active Ingredient

Hydrocortisone 1%

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

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

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

Purpose

Anti-Itch

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.

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

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)

Drug Facts (DRUG FACTS)

Active Ingredient (Active ingredient)

Hydrocortisone 1%

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)