CALENDULA DIAPER RASH- zinc oxide cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)

Available from:

Weleda AG

INN (International Name):

ZINC OXIDE

Composition:

ZINC OXIDE 12 g in 100 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Diaper Rash Cream Uses Offers temporary, quick and effective relief for minor skin irritations due to diaper rash. Minor skin irritations. Reliable protection from dampness.

Authorization status:

OTC monograph final

Summary of Product characteristics

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)
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)
CALENDULA DIAPER RASH
zinc oxide cream
PRODUCT INFORMATION
PRODUCT T YPE
HUMAN OTC DRUG
ITE M CODE (SOURCE )
NDC:0 20 1-40 0 8
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRE NG TH
ZINC O XIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)
ZINC OXIDE
12 g in 10 0 g
INACTIVE INGREDIENTS
INGREDIENT NAME
STRE NG TH
YELLO W WAX (UNII