Active Ingredient
Zinc Oxicd 25%
Zinc Oxide
FDA Label NDC 82751-103
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Kindred Bravely for the product Zinc Oxide (NDC 82751-103). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Skin Protectant
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
avoid contact with eyes
Stop Use And Ask A Doctor
if symptoms last more than 7 days or clears up and occurs again within a few days.
Keep Out Of Reach Of Children
If swallowed get medical help or contact a Poison Control Center right away.
Directions
Shake well before use
Change wet and soiled diapers promptly, cleanse the diaper area, and allow to dry
Spray 4-6 inches away from skin.
Spray product liberally as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
No need to rub in.
Inactive Ingredients
Aqua (Water), Helianthus annuus (Sunflower) Oil, Simmondsia chinensis (Jojoba) Seed Oil, Ricinus communis (Castor) Seed Oil, Butyrospermum parkii (Shea) Butter, Cetearyl Alcohol, Cetearyl Glucoside, Organic Aloe barbadensis (Aloe vera) Leaf Juice, Glyceryl Caprylate, Caprylhydroxamic Acid, Xanthan Gum.
Otc - Questions
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3913 Oceanic Drive, Suite 502
Oceanside, CA 92056
888-850-3756
www.kindredbravely.com
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