CALENDULA DIAPER RASH- zinc oxide cream

CALENDULA DIAPER RASH by

Drug Labeling and Warnings

CALENDULA DIAPER RASH by is a Otc medication manufactured, distributed, or labeled by Weleda AG, Weleda, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredient

Zinc Oxide 12%

PURPOSE

Purpose

Diaper Rash Cream

KEEP OUT OF REACH OF CHILDREN

Store out of 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.

Store at controlled room temperature, out of reach of children.

Do not use if safety seal under cap is broken or missing.

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 Tonkinensis Resin, Sweet Almond Oil, Water.

PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby

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 0.22 OZ (6.3g)

PRINCIPAL DISPLAY PANEL

Weleda

Since 1921

Baby

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 2.9 OZ (81g)

INGREDIENTS AND APPEARANCE

CALENDULA DIAPER RASH 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0201-4008
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 TONKINENSIS RESIN (UNII: QB299X2IBD)
ALMOND OIL (UNII: 66YXD4DKO9)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0201-4008-53	81 g in 1 TUBE; Type 0: Not a Combination Product	11/27/2017
2	NDC: 0201-4008-21	6.3 g in 1 TUBE; Type 0: Not a Combination Product	11/27/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	11/27/2017

Labeler - Weleda AG (480021922)

Registrant - Weleda, Inc. (012301297)

Establishment
Name	Address	ID/FEI	Business Operations
Weleda AG		480021922	manufacture(0201-4008)