Careall Anti-itch Cream
FDA Label NDC 51824-088

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by New World Imports, Inc for the product Careall Anti-itch (NDC 51824-088). 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 active ingredients, purpose, keep out of reach of children, uses, warnings, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Diphenhydramine Hydrochloride 2%

Zinc Acetate 0.1%

Purpose

Diphenhydramine Hydrochloride 2%....Topical Analgesic

Zinc Acetate 0.1%.............................Skin Protectant

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.

Uses

Uses

  • temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy / poison oak / poison sumac.
  • dries the oozing and weeping of poison ivy, poison oak and poison sumac.

Warnings

For external use only.

Due not use:

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth.

    • Ask a doctor before use:

    • on chicken pox
    • on measles

      • When using this product avoid contact with eyes

      Stop use and ask a doctor if:

      • condition worsens or does not improve within 7 days
      • symptoms persists for more than 7 days or clear up and occur again within a few days

Directions

  • do not use more than directed
  • 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

Inactive Ingredients

cetyl alcohol, glyceryl monostearate, glycerin, methylparaben, propylparaben, carbopol 980, light liquid paraffin, polysorbate 60, stearic acid, purified water

* Please review the disclaimer below.