Otc - Active Ingredient
Zinc Oxide 20%
Zinc Oxide
FDA Label NDC 61554-100
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Gentell, Inc. for the product Zinc Oxide (NDC 61554-100). 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, indications & usage, warnings, otc - when using, otc - stop use, otc - ask doctor, otc - do not use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Indications & Usage
Uses
dries the oozing and weeping of:
- poison ivy
- poison oak
- poison sumac
Warnings
Warnings
For external use only
When using this product
- do not get into eyes
- condition worsens
- symptoms last more than 7 days or clear up and occur again within a few days
- deep puncture wounds
- animal bites
- serious burns
Stop use and ask a doctor if
Do not use on
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Otc - When Using
When using this product
- do not get into eyes
Otc - Stop Use
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 - Ask Doctor
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 - Do Not Use
Do not use on
- deep puncture wounds
- animal bites
- serious burns
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Other Safety Information
For external use only
If swallowed, get medical help or contact a Poison Control Center right away.
Instructions For Use
Directions
- apply as needed
Dosage & Administration
apply as needed
Storage And Handling
Other Information
store between 15°C to 30°C (59°F to 86°F)
avoid excessive heat
Inactive Ingredient
Inactive ingredients
light mineral oil, petrolatum
Otc - Questions
Questions?
Call 800-840-9041 Monday through Friday 9:00 AM to 5:00 PM EST
Package Label.Principal Display Panel
Gentell ® We make it better
GEN-23400
Zn Oxide
Zinc Oxide Ointment
Skin Protectant
16 oz. (454g)
Gentell 2701 Bartram Road, Bristol, PA 19007 www.gentell.com
* Please review the disclaimer below.
