bbb52558-6e91-4aa7-853c-7fad1650283d

SPL v1
SPL
SPL Set ID bbb52558-6e91-4aa7-853c-7fad1650283d
Route
topical
Published
Effective Date 2017-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
hydrocortisone (1 g)
Inactive Ingredients
alpha-tocopherol acetate ascorbic acid butylated hydroxytoluene ceteth-20 cetyl alcohol chamomile flower oil aloe vera leaf methylparaben mineral oil propylene glycol propylparaben sodium hydroxide sorbitan monostearate stearyl alcohol vitamin a palmitate water

Identifiers & Packaging

Marketing Status
otc monograph not final active Since 2017-04-20

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 irriation, 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 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:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea

Description

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

Section 44425-7

Other information

  • store at room temperature 20°-25°C (68°-77°F)
  • lot no. & exp. date: see box or see crimp of tube
Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not pull 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.
Section 51727-6

Inactive ingredients

alpha-tocopherol acetate, ascorbig acid, butylated hydroxtoluene, ceteth-20, cetyl alcohol, chamomile flower oil, decolorized aloe vera leaf,

methylparaben, mineral oil, propylene glycol, propylparaben, sodium hydroxide, sorbitan monostearate, stearyl alcohol, vitamin A palmitate,

water

Section 51945-4

Section 55105-1

Uses

  • temporarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
  • eczema
  • insect bites
  • cosmetics
  • psoriasis
  • detergents
  • soaps
  • poison ivy, oak, sumac
  • jewelry
  • seborrheic dermatitis
  • temporarily relieves external anal and genital itching
  • other uses of this product should only be under the advice and supervison 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 irriation, 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 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:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea

Section 44425-7 (44425-7)

Other information

  • store at room temperature 20°-25°C (68°-77°F)
  • lot no. & exp. date: see box or see crimp of tube
Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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 the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not pull 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.
Section 51727-6 (51727-6)

Inactive ingredients

alpha-tocopherol acetate, ascorbig acid, butylated hydroxtoluene, ceteth-20, cetyl alcohol, chamomile flower oil, decolorized aloe vera leaf,

methylparaben, mineral oil, propylene glycol, propylparaben, sodium hydroxide, sorbitan monostearate, stearyl alcohol, vitamin A palmitate,

water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Uses

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

Advanced Ingredient Data


Raw Label Data

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