White Mallow diaper Rash Cream

White Mallow diaper Rash Cream
SPL v1
SPL
SPL Set ID 1bc9f5e8-5e3e-43af-9e07-a8c757cd4d71
Route
TOPICAL
Published
Effective Date 2014-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (14 g)
Inactive Ingredients
Borage Oil Coconut Oil Glyceryl Caprylate Glyceryl Oleate Glycerin Yellow Wax Lactic Acid Lanolin Sesame Oil Sodium Caproyl Lactylate Sodium Lauroyl Lactylate Sunflower Oil Almond Oil Viola Tricolor Water Althaea Officinalis Root White Wax

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2014-08-22

Description

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)


Medication Information

Warnings and Precautions

Warnings

External use only.

Avoid contact with eyes.

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

Indications and 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.

Dosage and 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.

Description

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)

Section 50565-1

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

Section 51727-6

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.

Section 51945-4

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)

Section 55105-1

Purpose

Diaper Rash Cream

Section 55106-9

Active ingredient

Zinc Oxide 14%


Structured Label Content

Indications and Usage (34067-9)

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.

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

Warnings

External use only.

Avoid contact with eyes.

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

Section 50565-1 (50565-1)

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

Section 51727-6 (51727-6)

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.

Section 51945-4 (51945-4)

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)

Section 55105-1 (55105-1)

Purpose

Diaper Rash Cream

Section 55106-9 (55106-9)

Active ingredient

Zinc Oxide 14%


Advanced Ingredient Data


Raw Label Data

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