CALENDULA DIAPER RASH- zinc oxide cream
Weleda AG

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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CALENDULA DIAPER RASH CREAM

Active ingredient

Zinc Oxide 12%

Purpose

Diaper Rash Cream

Store out of reach of children.

Uses

Offers temporary, quick and effective relief for minor skin irritations due to diaper rash.

Minor skin irritations.

Reliable protection from dampness.

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.

Directions

Cleanse area, pat dry, then apply a thin layer of cream.

Apply to the whole diaper area after careful cleaning.

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.

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)

MINI BOX MINI TUBE

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)

LARGE BOX

PACKAGE INSERT PAGE 1

LARGE TUBE PACKAGE INSERT PAGE 2

CALENDULA DIAPER RASH
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0201-4008
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:0201-4008-53	81 g in 1 TUBE; Type 0: Not a Combination Product	11/27/2017	11/17/2020
2	NDC:0201-4008-21	6.3 g in 1 TUBE; Type 0: Not a Combination Product	11/27/2017	11/17/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part347	11/27/2017	11/17/2020

Labeler - Weleda AG (480021922)

Registrant - Weleda, Inc. (012301297)

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

Revised: 11/2020

Document Id: 6292a1ab-e513-4f9d-b740-61f92d48086f

Set id: c71b2ed3-1c60-4450-b40d-17d99d64ae94

Version: 2

Effective Time: 20201117

Weleda AG