PURISTICS BABY ZINC OXIDE DIAPER RASH- zinc oxide cream

puristics baby zinc oxide diaper rash by

Drug Labeling and Warnings

puristics baby zinc oxide diaper rash by is a Otc medication manufactured, distributed, or labeled by Scerene Healthcare, Inc., BioZone Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Zinc oxide 15.0%

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

Stop use and ask a doctor if

• condition worsens

• symptoms last more than 7 days or clear up and occur again in a few days

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

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

INGREDIENTS AND APPEARANCE

PURISTICS BABY ZINC OXIDE DIAPER RASH  
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76026-200
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	15 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76026-200-30	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part347	12/20/2010

Labeler - Scerene Healthcare, Inc. (832688209)

Establishment
Name	Address	ID/FEI	Business Operations
BioZone Laboratories, Inc		555564293	MANUFACTURE