Otc - Active Ingredient
Zinc Oxide 14.9%
Diaper Rash Cream Happy Cheeks Cream
FDA Label NDC 84568-549
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Dimples Bath Co. Llc for the product Diaper Rash Cream Happy Cheeks (NDC 84568-549). 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, uses, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectorant
Uses
Helps treat and prevent diaper rash. Protects minor skin irritation associated with diaper rash. Helps seal out wetness
Warnings
For external use only
When using this product • do not get into eyes
Stop use and ask a doctor if
• Condition worsens • Symptoms last more than 7 days or clear up and occur again within a few days
Otc - Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center immediately
Dosage & Administration
Change wet and soild diapers promptly, cleanse the diaper area, and allow to dry. Shake well before use. Spray 4-6 inches away from the skin. Spray product liberally as often as needed, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged. No need to rub in
Inactive Ingredient
Aloe Barbadensis Leaf Juice, Bentonite, Butyrospermum Parkii (Shea) Butter, Caprylhydroxamic Acid, Caprylyl Glycol, Cellulose Gum, Cetearyl Alcohol, Coco Glucoside, Glycerin, Glyceryl Oleate, Glyceryl Rosinate, Microcrystalline Cellulose, Olea Europaea (Olive) Fruit Oil, Olea Europaea (Olive) Oil Unsaponifiables, Propanediol, Ricinus Communis (Castor) Seed Oil, Water
Other Safety Information
Protect this product from excessive heat and direct sun • May stain some fabrics and surfaces
Otc - Questions
212-627-0377 M-F 9am to 5pm EST
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