FDA Label for Harris Teeter Anti-itch Intensive Healing

View Indications, Usage & Precautions

Harris Teeter Anti-itch Intensive Healing Product Label

The following document was submitted to the FDA by the labeler of this product Harris Teeter. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active ingredient                                           Purpose

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


Otc - Purpose



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

Warnings



Warnings

For external use only


Otc - Do Not Use



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.

Otc - When Using



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

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.


Indications & 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

Storage And Handling



Other information

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

Inactive Ingredient



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


Dosage & Administration



Distributed by:

Harris Teeter, LLC

Matthews, NC 28105

Made in Korea


Package Label.Principal Display Panel




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