WHITE MALLOW DIAPER RASH CREAM- zinc oxide cream 
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled

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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WHITE MALLOW DIAPER RASH CREAM

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)

LARGE BOXLEAFLET PAGE 1LEAFLET PAGE 2LARGE TUBE

Active ingredient

Zinc Oxide 14%

Purpose

Diaper Rash Cream

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

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

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.

Use after each diaper change until skin irritation heals, or as directed by a physician.

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.

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)

SACHET

WHITE MALLOW DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0164-2207
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0164-2207-6555.1 g in 1 TUBE
2NDC:0164-2207-663 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/22/2014
Labeler - Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled (315541862)
Establishment
NameAddressID/FEIBusiness Operations
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled315541862manufacture(0164-2207)

Revised: 8/2014
Document Id: 436b3d70-1250-4ad2-a8d9-ead21ada6ec2
Set id: 1bc9f5e8-5e3e-43af-9e07-a8c757cd4d71
Version: 1
Effective Time: 20140822
 
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled