Active Ingredient
Zinc Oxide 20 %
Zinc Oxide 20% Ointment
FDA Label NDC 69452-450
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Bionpharma Inc for the product Zinc Oxide 20% (NDC 69452-450). 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 if, 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
■ Dries the oozing and weeping of poison • ivy • oak • sumac
■ Helps treat and prevent diaper rash
■ Protects chafed skin due to diaper rash and 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
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
■ For poison ivy, oak & sumac: apply as needed
■ For Diaper Rash
- Change wet and soiled diapers promptly
- Cleanse the diaper area and allow to dry
- Apply ointment liberally as often as necessary, with each diaper change, especially at bed time or anytime when exposure to wet diapers may be prolonged
Other Information
■ Store at 15°C – 30°C (59°F – 86°F)
Inactive Ingredients
ceteareth 20, cetostearyl alcohol, light mineral oil, white petrolatum
Other
Manufactured for:
Bionpharma Inc.
Princeton, NJ 08540
MADE IN INDIA
L0000798
KBP0581L-0
R0324
GUJ/DRUGS/G/25/2134
Package Label.Principal Display Panel
NDC 69452-450-58
• dye-free • paraben-free
• phthalate-free • fragrance-free
a+ health TM
healing ointment
zinc oxide 20% / skin protectant
• protects chafed skin due to diaper rash and helps seal out wetness
• dries the oozing and weeping of poison ivy, oak and sumac
net wt. 15 oz
Image001 (Image001)
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