Qc 1% Hydrocortisone Cream Max. Strength 1 Oz 99260 (2019)

Qc 1% Hydrocortisone Cream Max. Strength 1 Oz 99260 (2019)
SPL v2
SPL
SPL Set ID 8dc1ac1e-de7f-44e1-e053-2a95a90a182e
Route
TOPICAL
Published
Effective Date 2019-07-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Light Mineral Oil Methylparaben Propylparaben Sorbitan Monooleate Steareth-20 Butylated Hydroxytoluene Cetostearyl Alcohol Propylene Glycol Stearic Acid

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2019-07-15
Description

Active ingredient Purpose Hydrocortisone 1%..................................................Anti-itch

Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean 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 applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Dosage and Administration

Distributed by:

C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

Description

Active ingredient Purpose Hydrocortisone 1%..................................................Anti-itch

Section 44425-7

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9

Stop use and ask a doctor

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Section 50567-7

When using this product

  • avoid contact with eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
  • more than directed unless directed by a doctor
Section 51727-6

Inactive ingredients

butylated hydroxytoluene, cetostearyl alcohol, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monooleate, steareth-20, stearic acid

Section 51945-4

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1

Uses

  • temporarily relieves itching associated with minor skin irritation, inflammation, and rashed due to
  • eczema
  • psoriasis
  • jewelry
  • insect bites
  • soaps
  • cosmetics
  • detergents
  • seborrheic dermatitis
  • poison ivy, oak sumac
Section 55106-9

Active ingredient Purpose

Hydrocortisone 1%..................................................Anti-itch

Structured Label Content

Indications and Usage (34067-9)

Directions

  • for itching of skin irritation, inflammation, and rashes:
  • 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: ask a doctor
  • for external anal and genital itching, adults:
  • when practical, clean 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 applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor
Dosage and Administration (34068-7)

Distributed by:

C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Made in China

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor

  • condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs
Section 50567-7 (50567-7)

When using this product

  • avoid contact with eyes
  • do not put directly into the rectum by using fingers or any mechanical device or applicator
Section 50570-1 (50570-1)

Do not use

  • in the genital area if you have a vaginal discharge. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor.
  • more than directed unless directed by a doctor
Section 51727-6 (51727-6)

Inactive ingredients

butylated hydroxytoluene, cetostearyl alcohol, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sorbitan monooleate, steareth-20, stearic acid

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Uses

  • temporarily relieves itching associated with minor skin irritation, inflammation, and rashed due to
  • eczema
  • psoriasis
  • jewelry
  • insect bites
  • soaps
  • cosmetics
  • detergents
  • seborrheic dermatitis
  • poison ivy, oak sumac
Section 55106-9 (55106-9)

Active ingredient Purpose

Hydrocortisone 1%..................................................Anti-itch

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:57.307633 · Updated: 2026-03-14T22:55:46.109144