Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide 15% ..................................... Skin Protectant
Diaper Rash Cream
FDA Label NDC 72381-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Hamilton Therapeutics, Inc for the product Diaper Rash Cream (NDC 72381-101). 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 otc - active ingredient, otc - purpose, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Uses Helps treat and prevent diaper rash. Protects
chafed skin due to diaper rash and helps seal out wetness.
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.
Indications & Usage
Stop use and ask adoctor if
• condition worsens
• symptoms last more than 7 days or clear up and occur again within a few days.
Warnings
WarningsFor external use only.
When using this product • Avoid contact with eyes
Dosage & Administration
Directions
• Change wet and soiled diapers promptly.
• Cleanse the diaper area and allow to dry. • Apply cream liberally as often as necessary, with each diaper change,
especially at bedtime or anytime when exposure to wet diapers may be prolonged.
Inactive Ingredient
Inactive ingredients Helianthus Annuus (Sunflower) Seed Oil, Beeswax (Cera Alba), Polyhydroxystearic Acid, Butyrospermum Parkii (Shea Butter), Calophyllum Tacamahaca (Tamanu) Seed Oil, Olea Europaea (Olive) Fruit Oil, Cocos Nucifera (Coconut) Oil, Honey, Chamomilla Recutita (Matricaria) Flower Extract, Citrus Aurantium Amara (Bitter Orange) Flower Extract, Citrus Aurantium Dulcis (Orange) Peel Extract, Citrus Limon (Lemon) Peel Extract, Salvia Officinalis (Sage) Leaf Extract, Thymus Vulgaris (Thyme) Flower/Leaf Extract,Tocopherol, Squalene, Sterols, Monoglycerides.
Package Label.Principal Display Panel
Diaper Rash Cream
3.3 FL OZ / 98mL
Diaper Rash Cream (Diaper Rash Cream3 3oz Tube)
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