Vitamins A And D Diaper Rash
FDA Label NDC 11822-3401

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rite Aid for the product Vitamins A And D Diaper Rash (NDC 11822-3401). 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, warnings, when using this product, stop using this product and ask doctor if, do not use on, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

LANOLIN 15.5 PERCENT

PETROLATUM 53.4 PERCENT

Purpose

SKIN PROTECTANT

SKIN PROTECTANT

Uses

HELPS TREAT AND PREVENT DIAPER RASH.

TEMPORARILY PROTECTS MINOR: CUTS SCRAPES BURNS.

TEMPORARILY PROTECTS AND RELIEVES CHAPPED, CHAFE OR CRACKED SKIN AND LIPS.

HELPS PROTECT FROM THE DRYING EFFECTS OF WIND AND COLD WEATHER.

Warnings

FOR EXTERNAL USE ONLY.

When Using This Product

AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.


Stop Using This Product And Ask Doctor If

CONDITION WORSENS

SYMPTOMS LAST FOR MORE THAN 7 DAYS OR CLEAR UP AND OCCUR AGAIN WITHIN A FEW DAYS


Do Not Use On

DEEP OR PUNCTURE WOUNDS

ANIMAL BITES

SERIOUS BURNS

Keep Out Of Reach Of Children

IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

Directions

FOR SKIN PROTECTANT USE APPLY AS NEEDED

FOR DIAPER RASH USE

    CHANGE WET AND SOILED DIAPERS PROMPTLY

     CLEAN THE DIAPER AREA, AND ALLOW TO DRY

     APPLY OINTMENT AS OFTEN AS REQUIRED, WITH EACH DIAPER CHANGE, ESPECIALLY AT BEDTIME OR ANYTIME WHEN EXPOSURE TO WET DIAPERS MAY BE 

     PROLONGED.

Inactive Ingredients

COD LIVER OIL, FRAGRANCE, LIGHT MINERAL OIL, MICROCRYSTALLINE WAX, PARAFFIN.

Questions Or Comments

1-866-695-3030

Other Information

STORE BETWEEN 20 DEGREES CELSIUS TO 25 DEGREES CELSIUS (68 DEGREES FAHRENHEIT TO 77 DEGREES FAHRENHEIT).

Package Label.Principal Display Panel

Image Of Ra1 (Ra1)

Image Of Ra1 (Ra1)

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