Baby Diaper Rash
FDA Label NDC 52810-216

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Puremedy for the product Baby Diaper Rash (NDC 52810-216). 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, indications & usage, dosage & administration, inactive ingredient, warnings, otc - keep out of reach of children, storage and handling, 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

ORG. CALENDULA OFFICINALIS (1X) HPUS) (MARIGOLD)

ORG. SAMBUCUS NIGRA (1X) HPUS (ELDER BARK AND FLOWER)

Otc - Purpose

PURPOSE

SOOTHES RASH, IRRITATION

REMEDY FOR SWELLING

Indications & Usage

USES: TO RELIEVE SYMPTOMS ASSOCIATED WITH DIAPER RASH AND MINOR SKIN IRRITATIONS. SOOTHES SKINS AND PROTECTS AGAINST MOISTURE TP PROMOTE HEALING.

Dosage & Administration

DIRECTIONS: APPLY TO CLEAN SKIN AFTER EACH DIAPER CHANGE OR AS DIRECTED BY YOUR PHYSICIAN. MAY ALSO BE USED AS A DAILY SKIN PROTECTANT.

Inactive Ingredient

INACTIVE INGREDIENTS: ORG. OLIVE OIL, ORG. BEESWAX, MILD PROPRIETARY BLEND OF PINE AND FIR EXTRACTS, ORG. COCOA BUTTER, ORG. MILK THISTLE, ORG. ST. JOHN'S WORT, ORG. ALOE VERA GEL, ORG. NON-GMO VITAMIN E

Warnings

WARNINGS: DO NOT USE IF ALLERGIC TO OR SENSITIVE TO ANY INGREDIENT IN THIS SALVE. TEST FOR ALLERGY BY RUBBING A SMALL AMOUNT ON SKIN BEFORE USE. IF CONDITION PERSISTS OR WORSENS AFTER 3 DAYS SEE A DOCTOR. AVOID DIRECT CONTACT WITH EYES. USE ONLY AS DIRECTED. KEEP ALL DRUGS OUT OF USE OF CHILDREN. SAFE TO USE FOR ALL AGES.

Otc - Keep Out Of Reach Of Children

KEEP ALL DRUGS OUT OF REACH OF CHILDREN.

Storage And Handling

STORE IN A COOL DRY PLACE OR REFRIGERATE.

Otc - Questions

CUSTOMER SERVICE 818-851-9014

* Please review the disclaimer below.