CALENDULA DIAPER RASH CREAM- zinc oxide cream

CALENDULA DIAPER RASH CREAM by

Drug Labeling and Warnings

CALENDULA DIAPER RASH CREAM by is a Otc medication manufactured, distributed, or labeled by Weleda, Inc., Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 12%

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

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.

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 0.4 OZ (10.8g)

PRINCIPAL DISPLAY PANEL

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)

INGREDIENTS AND APPEARANCE

CALENDULA DIAPER RASH CREAM 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55946-701
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	12 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
YELLOW WAX (UNII: 2ZA36H0S2V)
CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)
CANANGA OIL (UNII: 8YOY78GNNX)
CHAMOMILE (UNII: FGL3685T2X)
CITRUS AURANTIUM LEAFY TWIG OIL (UNII: 5K6H1IMT3D)
CLARY SAGE OIL (UNII: 87L0D4U3M0)
GLYCERYL MONOLINOLEATE (UNII: 4763AXI84L)
HECTORITE (UNII: 08X4KI73EZ)
LANOLIN (UNII: 7EV65EAW6H)
LAVENDER OIL (UNII: ZBP1YXW0H8)
ORANGE OIL (UNII: AKN3KSD11B)
ROSEMARY OIL (UNII: 8LGU7VM393)
SAGE OIL (UNII: U27K0H1H2O)
SESAME OIL (UNII: QX10HYY4QV)
STYRAX BENZOIN RESIN (UNII: FE663Z8IRO)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55946-701-53	81 g in 1 TUBE
2	NDC: 55946-701-54	10.8 g in 1 TUBE
3	NDC: 55946-701-49	1.5 g in 1 POUCH

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	07/16/2013

Labeler - Weleda, Inc. (012301297)

Registrant - Weleda, Inc. (012301297)

Establishment
Name	Address	ID/FEI	Business Operations
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled		315541862	manufacture(55946-701)