Winco Hydrocortisone Cream Intensive Healing 1oz 24198 Zdp

Winco Hydrocortisone Cream Intensive Healing 1oz 24198 Zdp
SPL v5
SPL
SPL Set ID ac4e0e24-9295-b83b-e053-2995a90a996f
Route
TOPICAL
Published
Effective Date 2020-08-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (10 mg)
Inactive Ingredients
Menthyl Lactate, (-)- Methylparaben Polysorbate 60 Propylene Glycol Propylparaben Dimethicone 350 Glyceryl Stearate/peg-100 Stearate Magnesium Ascorbyl Phosphate Matricaria Chamomilla Flowering Top Petrolatum Water Aloe Vera Leaf Steareth-2 Vitamin A Palmitate Stearyl Alcohol Glycerin Methyl Gluceth-20 Steareth-21 Cetyl Alcohol Edetate Disodium Gelatin Hydrolysate (porcine Skin, Mw 3000) .alpha.-tocopherol Acetate Benzyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-08-07

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:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN CHINA

Description

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

Section 44425-7

Other information

  • store at room temperature 20-25ºC (68-77ºF)
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 finger 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 ingredientsaloe 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 ivy, oak, sumac

temporarily relieves external anal and genital itching

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

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:

WINCO FOODS, LLC,

BOISE, ID 83704

MADE IN CHINA

Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20-25ºC (68-77ºF)
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 finger 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 ingredientsaloe 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 ivy, oak, sumac

temporarily relieves external anal and genital itching

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

Section 55106-9 (55106-9)

Active ingredient........................................................................Purpose

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


Advanced Ingredient Data


Raw Label Data

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