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DRUG FACTS
Attitude Diaper Cream Zinc Unscented Stick
FDA Label NDC 61649-260
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by 9055-7588 Quebec Inc. (attitude) for the product Attitude Diaper Cream Zinc Unscented (NDC 61649-260). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, otc - active ingredient, otc - purpose, indications & usage, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Active Ingredient
Zinc oxide (15%)
Otc - Purpose
Skin protectant - Diaper rash treatment
Indications & Usage
Helps prevent diaper rash.
Protects chafed irritated skin due to diaper rash.
Helps protect from wetness that causes diaper rash.
Temporarily protects and helps relieve minor skin irritation due to diaper rash.
Helps treat/heal diaper rash.
Warnings
Allergens: almond
For external use only.
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Stop Use
Stop use and consult a doctor if symptoms worsen or last for more than 7 days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, call a poison control centre or get edical help right away.
Dosage & Administration
Change wet and soiled diapers promptly, cleanser the diaper area, and allow to dry. Push on the bottom to release the product. Heat the product for a few seconds on your hands and apply on baby's bottom. Apply product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. If necessary, after use, wipe off the excess on the tube contour before closing it.
Storage And Handling
Store at temperatures below 90 F (32 C).
Inactive Ingredient
Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Polyhydroxystearic Acid, Caprylic/Capric Triglyceride, Helianthus Annuus (Sunflower) Seed Wax, Vitis Vinifera (Grape) Seed Oil, C10-18 Triglycerides, Behenyl Behenate, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Glyceryl Behenate, Euphorbia Cerifera (Candelilla) Wax, Vaccinium Myrtillus (Blueberry) Leaf Extract.
Package Label.Principal Display Panel
ATTITUDETM
natural care
baby leavesTM
diaper cream - zinc
protects & nourishes
Unscented
EWG VerifiedTM
Vegan
Stick 30g /1 oz.
NPN 80119243
dermatologically tested
plastic free
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