White Mallow Diaper Rash Cream
FDA Label NDC 0164-2207

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 White Mallow Diaper Rash Cream (NDC 0164-2207). 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 Derma

White Mallow

Diaper Rash Cream

Relieves and protects

Sensitive Skin - Fragrance free

Mauve Blanche

Crème contre l`Erythème Fessier

Soulage et protège

Peau sensible - Sans parfum

Certified Natural Baby Care      

Le Soin Naturel Authentique

NPN 80044523

NET WT / POIDS NET 1.9 OZ (55.1g)

Large Box (Largeboxwhitemallowdiaperrashcr)

Large Box (Largeboxwhitemallowdiaperrashcr)

Leaflet Page 1 (Leafletwhitemallowdiaperrashcr P1)

Leaflet Page 1 (Leafletwhitemallowdiaperrashcr P1)

Leaflet Page 2 (Leafletwhitemallowdiaperrashcr P2)

Leaflet Page 2 (Leafletwhitemallowdiaperrashcr P2)

Large Tube (Largetubewhitemallowdiaperrashcr)

Large Tube (Largetubewhitemallowdiaperrashcr)

Weleda

Since 1921

Baby Derma

White Mallow

Diaper Rash Cream

Sensitive Skin - Fragrance free

Mauve Blanche

Crème contre l'Erythème Fessier

Peau sensible - Sans parfum

Certified Natural Baby Care

Le Soin Naturel Authentique

NET WT / POIDS NET 0.1 OZ (3g)

Sachet (Sachetwhitemallowdiaperrashcr)

Sachet (Sachetwhitemallowdiaperrashcr)

Otc - Active Ingredient

Active ingredient

Zinc Oxide 14%

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

Temporarily helps to relieve minor skin irritations due to diaper rash.

Protects chafed skin from minor skin irritations, for sensitive skin.

Helps protect from wetness that causes diaper rash.

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.

Use after each diaper change until skin irritation heals, or as directed by a physician.

Inactive Ingredient

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

Borage Oil, Coconut Oil, Glyceryl Caprylate, Glyceryl Oleate, Glycerin, Hydrolyzed Beeswax, Lactic Acid, Lanolin, Sesame Seed Oil, Sodium Caproyl Lactylate, Sodium Lauroyl Lactylate, Sunflower Oil Unsaponifiables, Sweet Almond Oil, Viola tricolor Extract, Water, White Mallow (Althaea officinalis) Root Extract, White Wax.

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