Family Care Maximum Strength Medicated Anti Itch Cream
FDA Label NDC 65923-104

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by United Exchange Corp. for the product Family Care Maximum Strength Medicated Anti Itch (NDC 65923-104). 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 - when using, otc - stop use, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients                                                                                           Purpose

Menthol 1%..................................................................................Anti-itch, Pain Relief

Pramoxine Hydrochloride 1%.........................................................Anti-itch, Pain Relief

Otc - Purpose

Uses For temporary relief of pain and itch associated with:

  • minor skin irritations
  • minor cuts
  • minor burns
  • minor sunburns
  • rashes due to poison ivy, oak, or sumac
  • insect bites
  • scrapes

Warnings

Warnings For external use only.

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few days.

Otc - Keep Out Of Reach Of Children

Keep out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

Indications & Usage

Directions

  • Adults and children 2 years and older apply freely to affected area 3 to 4 times daily.
  • Children under 2 years: consult a doctor.

Storage And Handling

Other information

  • Store between 20°C and 25°C (68°F and 77°F)
  • Lot No. and Exp Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients aloe vera leaf, carbomer 940, glycerin, glyceryl monostearate, isopropyl myristate, methylparaben, methyl salicylate, mineral oil, polysorbate 60, propylparaben, stearyl alcohol, tocopheryl acetate, trolamine, water

Dosage & Administration

Distributed By:

United Exchange Corp.

17211 Valley View Ave.

Cerritos, CA 90703 USA

Made in Korea

* Please review the disclaimer below.