Dimethicone And Zinc Oxide
FDA Label NDC 59779-082

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cvs for the product Dimethicone And Zinc Oxide (NDC 59779-082). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredients                       PurposeDimethicone 1%........................Diaper rash cream Zinc Oxide 10%........................Diaper rash cream

Otc - Purpose

Active ingredients                       PurposeDimethicone 1%........................Diaper rash cream Zinc Oxide 10%........................Diaper rash cream

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.

Indications & Usage

Uses- helps treat and prevent diaper rash- protects minor skin irritation due to diaper rash andhelps seal out wetness

Warnings

Warnings For external use only. When using this product- do not get into eyesStop use and ask a doctor if:- condition worsens- symptoms last more than 7 days or clear up and occur again within several days

Dosage & Administration

Directions- change wet and soiled diapers promptly- cleanse the diaper area and allow to dry- apply cream liberally as often as necessary witheach diaper change, especially at bedtime or anytimewhen exposure to wet diapers may be prolongedOther informationStore between 20 degrees to 25 degrees C (68 degrees to 77 degrees F)

Inactive Ingredient

Inactive Ingredients aloe barbadensis extract,benzyl alcohol, coconut oil, cod liver oil (containsvitamin A and vitamin D), fragrance, glyceryl oleate, light mineral oil, ozokerite, paraffin, propylene glycol, sorbitol, synthetic beeswax, water

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