White Mallow Diaper Rash Cream (Zinc Oxide) Cream [Weleda, Inc.] -

WHITE MALLOW DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]
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NDC	55946-702-65, 55946-702-66
Set ID	62693e3b-2e38-4b23-962d-c1661706cfbb
Category	HUMAN OTC DRUG LABEL
Packager	Weleda, Inc.
Generic Name
Product Class
Product Number
Application Number	PART347

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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)
ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 14%
PURPOSE

Purpose

Diaper Rash Cream
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.
PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

WHITE MALLOW DIAPER RASH CREAM
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55946-702
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
BORAGE OIL (UNII: F8XAG1755S)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)
GLYCERYL OLEATE (UNII: 4PC054V79P)
GLYCERIN (UNII: PDC6A3C0OX)
YELLOW WAX (UNII: 2ZA36H0S2V)
LACTIC ACID (UNII: 33X04XA5AT)
LANOLIN (UNII: 7EV65EAW6H)
SESAME OIL (UNII: QX10HYY4QV)
SODIUM CAPROYL LACTYLATE (UNII: 87WR3BHC09)
SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)
SUNFLOWER OIL (UNII: 3W1JG795YI)
ALMOND OIL (UNII: 66YXD4DKO9)
VIOLA TRICOLOR (UNII: 9Q24RAI43V)
WATER (UNII: 059QF0KO0R)
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)
WHITE WAX (UNII: 7G1J5DA97F)

#	Item Code	Package Description
Packaging
1	NDC:55946-702-65	55.1 g in 1 TUBE
2	NDC:55946-702-66	3 g in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	08/26/2014

Labeler - Weleda, Inc. (012301297)

Registrant - Weleda, Inc. (012301297)

Name	Address	ID/FEI	Business Operations
Establishment
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled		315541862	manufacture(55946-702)

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