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DRUG FACTS
Attitude Baby Leaves Diaper Cream - Unscented Cream
FDA Label NDC 61649-714
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 Baby Leaves Diaper Cream - Unscented (NDC 61649-714). 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 - do not use, otc - stop use, 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 (13%)
Otc - Purpose
Diaper rash treatment
Indications & Usage
Helps prevent and treat diaper rash • Helps protect from wetness that causes diaper rash.
Warnings
For external use only
Otc - When Using
When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
Otc - Do Not Use
Do not use on broken skin.
Otc - Stop Use
Stop use and consult a doctor if symptoms worsen, last for more than 7 days or recur after a few
days.
Otc - Ask Doctor
Stop use and consult a doctor if symptoms worsen, last for more than 7 days or recur after a few
days.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
right away.
Dosage & Administration
Directions: Infants and children. Change wet and soiled diapers promptly, cleanse the diaper
area, and allow to dry. Apply cream liberally onto clean, dry skin as often as necessary, with each
diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Inactive Ingredient
Water, Cocos Nucifera (Coconut) Oil, Caprylic/Capric Triglyceride, Tapioca Starch, Butyrospermum Parkii (Shea) Butter, Cetearyl Alcohol, Glycerin, Polyglyceryl-6 Polyhydroxystearate, Polyglyceryl-6 Polyricinoleate, Sodium Chloride, Euphorbia Cerifera (Candelilla) Wax, Jojoba Esters, Sodium Gluconate, Helianthus Annuus (Sunflower) Seed Wax, Polyhydroxystearic Acid, Polyglycerin-6, Stearalkonium Hectorite, Sodium Benzoate, Propylene Carbonate, Acacia Senegal Gum, Acacia Decurrens Flower Wax, Polyglycerin-3, Xanthan Gum, Chamomilla Recutita (Matricaria) Flower Extract, Tocopherol, Ascorbyl Palmitate, Vaccinium Myrtillus (Blueberry) Leaf Extract.
Otc - Questions
1-855-509-7225
Package Label.Principal Display Panel
ATTITUDE
Baby Leaves
Diaper cream
Unscented
13% zinc oxide
EWG verified
75g / 26 oz net wt.
NPN 80138662
dermatologically testeD
vegan
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