Otc - Active Ingredient
Zinc Oxide 12.8%
Multipurpose Ointment
FDA Label NDC 16864-041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc for the product Multipurpose (NDC 16864-041). 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, warnings, otc - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Skin Protectant
Warnings
For external use only.
Otc - When Using
do not get into eyes
Otc - Stop Use
■ 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 right away.
Dosage & Administration
■ change wet and soiled diapers promptly ■ cleanse the diaper area and allow skin to dry ■ apply ointment liberally as often
as necessary, with each diaper change, especially at bedtime or any time exposure to wet diapers may be prolonged
Storage And Handling
Store at room temperature 15-30C (59-86F)
Inactive Ingredient
avena sativa (oat) kernel extract, beeswax, bisabolol, cholesterol, dimethicone, glycerin, peg-10 dimethicone, pentaerythrityl tetraisostearate, sorbitan olivate, theobroma grandiflorum seed butter, water, white petrolatum, zea mays (corn) starch
Otc - Questions
1-800-345-0032 www.triplepaste.com
Other
2024 Distributed by Advantice Health, LLC
Bridgewater, NJ 08807
Indications & Usage
■ helps treat and prevent diaper rash ■ protects chafed skin due to diaper rash and helps protect from wetness
Package Label.Principal Display Panel
Triple Paste
12.8% zinc oxide / skin protectant
Rash Ointment
Multi-Purpose with Sheer Zinc
for diaper, face and body rash
Powerful portection with a lightweight feel
Fragrance free - Hypoallergenic
Net Wt. 2oz (57g)
* Please review the disclaimer below.
