Rezamid
FDA Label NDC 11086-022

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Summers Laboratories Inc for the product Rezamid (NDC 11086-022). 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, use, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

SULFUR 5%

RESORCINOL 2%

Purpose

ACNE TREATMENT LOTION

Use

DRIES UP ACNE PIMPLES, HELPS PREVENT NEW PIMPLES

Warnings

  • FOR EXTERNAL USE ONLY

Otc - Do Not Use

DO NOT USE

  • ON BROKEN SKIN
  • ON LARGE AREAS OF THE BODY

Otc - When Using

WHEN USING THIS PRODUCT

  • APPLY TO AFFECTED AREAS ONLY
  • DO NOT GET INTO EYES

  • skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time

Otc - Stop Use

STOP USE AND ASK A DOCTOR IF

  • IF SKIN IRRITATION OCCURS OR GETS WORSE

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.

Directions

  • shake very well before using
  • clean the skin thoroughly before applying this product
  • cover the entire affected area with a thin layer one to three times daily
  • because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce application to once a day or every other day

Inactive Ingredients

water, SD-40 alcohol 28%, zinc oxide, talc, titanium dioxide, propylene glycol, attapulgite, lauramide DEA, iron oxides, sodium bisulfite, PEG-8 laurate, parachlorometaxylenol, hydroxyethylcellulose, sodium chloride, sodium polynapthalene sulfonate, EDTA, methyl paraben, xanthan gum, butylparaben, fragrance, simethicone.

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