Your browser does not support JavaScript! CALENDULA DIAPER RASH CREAM (ZINC OXIDE) CREAM [WELEDA, INC.]
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CALENDULA DIAPER RASH CREAM (zinc oxide) cream
[Weleda, Inc.]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE: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.
Drug Label Sections

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)

LARGE TUBEPACKAGE INSERT PAGE 2PACKAGE INSERT PAGE 1LARGE BOX

Active ingredient

Zinc Oxide 12%

Purpose

Diaper Rash Cream

Keep this and all medicines out of the 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.

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

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 Benzoin Resin, Sweet Almond Oil, Water.

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)

MINI TUBE

MINI BOX

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)

SACHET

CALENDULA DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:55946-701
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE12 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
YELLOW WAX 
CALENDULA OFFICINALIS FLOWER 
CANANGA OIL 
CHAMOMILE 
CITRUS AURANTIUM LEAFY TWIG OIL 
CLARY SAGE OIL 
GLYCERYL MONOLINOLEATE 
HECTORITE 
LANOLIN 
LAVENDER OIL 
ORANGE OIL 
ROSEMARY OIL 
SAGE OIL 
SESAME OIL 
STYRAX BENZOIN RESIN 
ALMOND OIL 
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55946-701-5381 g in 1 TUBE
2NDC:55946-701-5410.8 g in 1 TUBE
3NDC:55946-701-491.5 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34707/16/2013
Labeler - Weleda, Inc. (012301297)
Registrant - Weleda, Inc. (012301297)
Establishment
NameAddressID/FEIBusiness Operations
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled315541862manufacture(55946-701)

Revised: 7/2013
 
Weleda, Inc.

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