Calendula Diaper Rash Cream
FDA Label NDC 0164-2189

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled for the product Calendula Diaper Rash Cream (NDC 0164-2189). 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 package label.principal display panel, 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

Package Label.Principal Display Panel

Weleda

Since 1921

Baby & Child

Calendula

Diaper Rash Cream

Relieves and protects

Crème contre l`Erythème Fessier

Soulage et protège                   

Certified Natural Baby Care      

Le Soin Naturel Authentique

NPN 80005250

NET WT / POIDS NET 2.8 OZ (81g)

Large Tube (Caldiaprashcreamlgtube)

Large Tube (Caldiaprashcreamlgtube)

Package Insert Page 2 (Caldiaprashcreampkgins Page 2)

Package Insert Page 2 (Caldiaprashcreampkgins Page 2)

Package Insert Page 1 (Caldiaprashcreampkgins Page 1)

Package Insert Page 1 (Caldiaprashcreampkgins Page 1)

Large Box (Caldiaprashcreamlgbox)

Large Box (Caldiaprashcreamlgbox)

Weleda

Since 1921

Baby & Child

Calendula

Diaper Rash Cream

Relieves and protects

Crème contre l'Erythème Fessier

Soulage et protège

Certified Natural Baby Care

Le Soin Naturel Authentique

NPN 80005250

NET WT / POIDS NET 0.4 OZ (10.8g)

Mini Tube (Caldiaprashcreamminitube)

Mini Tube (Caldiaprashcreamminitube)

Mini Box (Caldiaprashcreamminibox)

Mini Box (Caldiaprashcreamminibox)

Weleda

Since 1921

Baby & Child

Calendula

Diaper Rash Cream

Crème contre l'Erythème Fessier

Certified Natural Baby Care

Le Soin Naturel Authentique

NET WT / POIDS NET 0.05 OZ (1.5g)

Sachet (Caldiaprashcreamsachet)

Sachet (Caldiaprashcreamsachet)

Otc - Active Ingredient

Active ingredient

Zinc Oxide 12%

Otc - Purpose

Purpose

Diaper Rash Cream

Otc - Keep Out Of Reach Of Children

Keep this and all medicines out of the reach of children.

Indications & Usage

Uses

Offers temporary, quick and effective relief for minor skin irritations due to diaper rash.

Minor skin irritations.

Reliable protection from dampness.

Warnings

Warnings

External use only.

Avoid contact with eyes.

Keep this and all medicines out of the reach of children.

Dosage & Administration

Directions

Cleanse area, pat dry, then apply a thin layer of cream.

Apply to the whole diaper area after careful cleaning.

Inactive Ingredient

Inactive Ingredients (USA) / Non-Medicinal Ingredients (Canada):

Beeswax, Calendula Flower Extract, Cananga Oil, Chamomile Flower Extract, Citrus Aurantium Leafy Twig (Petitgrain) Oil, Clary Sage Oil, Glyceryl Linoleate, Hectorite, Lanolin, Lavender Oil, Orange Oil, Rosemary Oil, Sage Oil, Sesame Seed Oil, Styrax Benzoin Resin, Sweet Almond Oil, Water.

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