Meijer Anti Itch
FDA Label NDC 41250-338

12 label sections · Submitted to the FDA by Meijer, Inc. · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Meijer, Inc. for the product Meijer Anti Itch (NDC 41250-338). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                                  Purpose

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

Otc - Purpose

Uses

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

Otc - When Using

When using this product

  • avoid contact with the eyes
  • do not put 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, or if 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 the reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Indications & Usage

Direections

  • 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: consult 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: consult a doctor

Storage And Handling

Other information

  • store at 20°-25°C (68°-77°F)

Inactive Ingredient

Inactive ingredients

cetanol, methylparaben, propylparaben, sorbitan monostearate, stearyl alcohol, white petrolatum

Dosage & Administration

Distributed by:

Meijer Distribution, Inc.

Grand Rapids, MI 49544

Made in South Korea

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