FDA Label for White Mallow Diaper Rash Cream

View Indications, Usage & Precautions

White Mallow Diaper Rash Cream Product Label

The following document was submitted to the FDA by the labeler of this product Weleda A.g. Schw�bisch Gm�nd, Zweigniederlassung Der Weled. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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)

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)


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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