Extra Strength Cream
FDA Label NDC 52000-071

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Universal Distribution Centre Llc for the product Extra Strength (NDC 52000-071). 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 uses, other, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Distributed by:

Universal Distribution Centre LLC

96 Distribution Boulevard, Edison
NJ 08817

Otc - Do Not Use

Do not use

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

Otc - Ask Doctor

Ask a doctor before use

  • on chicken pox
  • on measles

Otc - When Using

When using this product avoid contact with eyes

Otc - Stop Use

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • 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 reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Inactive Ingredients

cetyl alcohol, diazolidinyl urea, methylparaben, polyethylene glycol monostearate 1000, propylene glycol, propylparaben, purified water

* Please review the disclaimer below.