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WHITE MALLOW DIAPER RASH CREAM

Medically reviewed on August 28, 2017

Dosage form: cream
Ingredients: ZINC OXIDE 14g in 100g
Labeler: Weleda, Inc.
NDC Code: 55946-702

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.

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)

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)

WHITE MALLOW DIAPER RASH CREAM 
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55946-702
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE14 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BORAGE OIL 
COCONUT OIL 
GLYCERYL CAPRYLATE 
GLYCERYL OLEATE 
GLYCERIN 
YELLOW WAX 
LACTIC ACID 
LANOLIN 
SESAME OIL 
SODIUM CAPROYL LACTYLATE 
SODIUM LAUROYL LACTYLATE 
SUNFLOWER OIL 
ALMOND OIL 
VIOLA TRICOLOR 
WATER 
ALTHAEA OFFICINALIS ROOT 
WHITE WAX 
Packaging
#Item CodePackage Description
1NDC:55946-702-6555.1 g in 1 TUBE
2NDC:55946-702-663 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34708/26/2014
Labeler - Weleda, Inc. (012301297)
Registrant - Weleda, Inc. (012301297)
Establishment
NameAddressID/FEIOperations
Weleda A.G. Schwäbisch Gmünd, Zweigniederlassung der Weled315541862manufacture(55946-702)

 
Weleda, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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