Anti-itch
FDA Label NDC 64048-5113

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Product Quest Mfg for the product Anti-itch (NDC 64048-5113). 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 ingredient                                purpose, uses, keep out of reach of the children, directions, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient                                Purpose

Hydrocortisone - 1.00%                       Anti-itch

Uses

For the temporary relief of itching associated with minor
skin irritation and rashes due to: • eczema • poison ivy, oak and
sumac • cosmetics • jewelry • soaps and detergents • insect
bites. Other uses of this product should be only under the advice
and supervision of a doctor.

Keep Out Of Reach Of The Children

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

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, consult a doctor


Inactive Ingredients

Citric Acid, Disodium EDTA, Glycerin, Poloxamer 188, Polysorbate 20, SD Alcohol 40-B, Water

* Please review the disclaimer below.