FDA Label for Diaper Rash Cream
View Indications, Usage & Precautions
Diaper Rash Cream Product Label
The following document was submitted to the FDA by the labeler of this product Hamilton Therapeutics, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide 15% ..................................... Skin Protectant
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
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