PURISTICS BABY ZINC OXIDE DIAPER RASH - zinc oxide cream 
Scerene Healthcare, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Diaper Rash Cream

Active Ingredient

Zinc oxide 15.0%

Purpose

Diaper rash cream

Uses

Warnings

For external use only

When using this product

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

Other Information

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

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

PURISTICS BABY ZINC OXIDE DIAPER RASH  
zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76026-200
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc Oxide15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
Yellow Wax (UNII: 2ZA36H0S2V)  
Caprylyl Glycol (UNII: 00YIU5438U)  
Chamomile (UNII: FGL3685T2X)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Eucalyptus Oil (UNII: 2R04ONI662)  
Rosewood Oil (UNII: F2522O5L7B)  
Glycerin (UNII: PDC6A3C0OX)  
Lonicera Caprifolium Flower (UNII: 5N1WD9784U)  
Hydrogenated Soybean Oil (UNII: A2M91M918C)  
Lecithin, Soybean (UNII: 1DI56QDM62)  
Panthenol (UNII: WV9CM0O67Z)  
Water (UNII: 059QF0KO0R)  
Hyaluronate Sodium (UNII: YSE9PPT4TH)  
Sucrose Stearate (UNII: 274KW0O50M)  
Almond Oil (UNII: 66YXD4DKO9)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76026-200-3085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34712/20/2010
Labeler - Scerene Healthcare, Inc. (832688209)
Establishment
NameAddressID/FEIBusiness Operations
BioZone Laboratories, Inc555564293MANUFACTURE

Revised: 2/2011
Document Id: 172c35eb-36de-a788-1b1f-8bc5100b0f34
Set id: a6cb4d79-3276-a01d-6d5f-ef624cbeb016
Version: 1
Effective Time: 20110207
 
Scerene Healthcare, Inc.