Family Care Anti-itch Relief Cream 0.5 Oz 494 Zdp

Family Care Anti-itch Relief Cream 0.5 Oz 494 Zdp
SPL v3
SPL
SPL Set ID deb09e89-9794-89a7-e053-2a95a90abdf8
Route
TOPICAL
Published
Effective Date 2022-05-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Hydrocortisone (1 g)
Inactive Ingredients
Light Mineral Oil Cetostearyl Alcohol Maltodextrin Methylparaben Propylene Glycol Water Sodium Lauryl Sulfate Sodium Cetostearyl Sulfate Calcium Acetate Monohydrate Aloe Vera Leaf Aluminium Sulfate Octadecahydrate Icodextrin Petrolatum Propylparaben White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-10

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
Dosage and Administration

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

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

Wehn 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, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

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
  • pssoriasis
  • 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 e 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
Dosage and Administration (34068-7)

Distributed by:

United Exchange Corp.

Cypress, CA 90630 USA

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 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)

Wehn 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, aluminum sulfate octadecahydrate, calcium acetate monohydrate, cetostearyl alcohol, dextrin, light mineral oil, maltodextrin, methylparaben, petrolatum, propylene glycol, propylparaben, purified water, sodium cetearyl sulfate, sodium lauryl sulfate, white wax

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
  • pssoriasis
  • 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 e 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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