Active Ingredient
Zinc oxide 15.0%
Puristics Baby Zinc Oxide Diaper Rash
FDA Label NDC 76026-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Scerene Healthcare, Inc. for the product Puristics Baby Zinc Oxide Diaper Rash (NDC 76026-200). 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, keep out of reach of children., directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Diaper rash cream
Uses
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
condition worsens
symptoms last more than 7 days or clear up and occur again in a few days
Stop use and ask a doctor if
Keep Out Of Reach Of Children.
If swallowed, get medical help or contact a Poison Control Center right away.
Directions
change wet and soiled diapers promptly
cleanse the diaper area, allow to dry
apply cream liberally, as often as necessary, with each diaper change, especially at bedtime or anytime when exposure to wet diapers may be prolonged
Other Information
store between 20° to 25°C (68° to 77°F)
to open, twist off cap and remove purity seal. Do not use if purity seal is missing or broken.
Inactive Ingredients
beeswax, caprylyl glycol (skin emollient), chamomile extract, citric acid, ethylhexylglycerin (skin emollient), eucalyptus oil/rosewood oil (calming blend of essential oils), glycerin, honeysuckle extract (natural preservative), hydrogenated soybean oil, lecithin (derived from soybeans), panthenol (pro-vitamin B), polylysine (natural preservative), purified water, sodium hyaluronate, sucrose distearate (derived from sugar), sucrose stearate, sunflower seed wax, sweet almond oil
Principal Display Panel
Label (Label)
new!
the power of pure™
puristics™
baby
ZINC OXIDE
Diaper Rash Cream
98% NATURAL
heals & protects
no harmful chemicals
NET WT 3 OZ (85 g)
discover the power of pure.
Learn more at www.puristics.com
©2010 Distributed by
Scerene Healthcare, Inc., Peapack, NJ 07977
1-877-267-0519
21000210
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