FDA Label for Calendula Diaper Rash Cream

View Indications, Usage & Precautions

Calendula Diaper Rash Cream Product Label

The following document was submitted to the FDA by the labeler of this product Weleda, Inc.. 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 & 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)

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)

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)


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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