Jj Care Cream
FDA Label NDC 43473-116

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Nantong Health & Beyond Hygienic Products Inc. for the product Jj Care (NDC 43473-116). 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, indications & usage, warnings, otc - stop use, otc - keep out of reach of children, storage and handling, dosage & administration, 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

Hydrocortisone 1%

Otc - Purpose

Purpose  Anti-itch

Indications & Usage

Uses

  • for temorary relief of itching associated with minor irritations and rashes
  • other uses of this product should be only under the advice and supervision of a doctor

Warnings

Warnings

For external use only.

Do not use

  • in the eyes
  • for the treatment of diaper rash. Consult a doctor

Otc - Stop Use

Stop use and ask a doctor

  • if condition worsens, or if symptoms persist for more than 7 days, or clears up and occurs again within a few days
  • with use of any other hydrocortisone products

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.

Storage And Handling

Other Information

  • Do not use if the packaging has been opened or damaged
  • Store at 15C - 25C

Dosage & Administration

Directions 

  • 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: do not use

Inactive Ingredient

Inactive ingredients

Cetearyl Alcohol, Ceteareth-20, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Mineral Oil, Petrolactum, Phenoxyethanol, Water

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