qc anti-itch cream intensive healing 1 oz 99198 (hydrocortisone)

qc anti-itch cream intensive healing 1 oz 99198 (hydrocortisone)
SPL v3
SPL
SPL Set ID 24c3eb99-92ac-658c-e063-6394a90ab51f
Route
topical
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (10 mg)
Inactive Ingredients
polysorbate 60 matricaria chamomilla flowering top petrolatum gelatin hydrolysate (porcine skin, mw 3000) water stearyl alcohol propylene glycol steareth-21 methyl gluceth-20 dimethicone 350 edetate disodium propylparaben cetyl alcohol glycerin glyceryl stearate/peg-100 stearate magnesium ascorbyl phosphate menthyl lactate methylparaben steareth-2 vitamin a palmitate aloe vera leaf alpha-tocopherol acetate benzyl alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-01-06

Description

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


Medication Information

Warnings and Precautions

Warnings

For external use only

Active Ingredient

Active ingredient Purpose

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

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

CDMA, Inc.

Novi, MI 48375

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 if

  • 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

aloe vera leaf, alpha-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl phosphate, matricaria chamomilla flowering top, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate

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 irritations, inflammation, and rashes due to:
  • eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison icy, oak, sumac
  • temporary relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Structured Label Content

Warnings and Precautions (34071-1)

Warnings

For external use only

Active Ingredient (55106-9)

Active ingredient Purpose

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

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

CDMA, Inc.

Novi, MI 48375

Made in China

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 if

  • 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

aloe vera leaf, alpha-tocopherol acetate, benzyl alcohol, cetyl alcohol, dimethicone 350, edetate disodium, gelatin hydrolysate, glycerin, glyceryl stearate/peg-100 stearate, magnesium ascorbyl phosphate, matricaria chamomilla flowering top, menthyl lactate, methyl gluceth-20, methylparaben, petrolatum, polysorbate 60, propylene glycol, propylparaben, purified water, steareth-2, steareth-21, stearyl alcohol, vitamin a palmitate

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 irritations, inflammation, and rashes due to:
  • eczema, psoriasis, jewelry, insect bites, soaps, cosmetics, detergents, seborrheic dermatitis, poison icy, oak, sumac
  • temporary relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)