Diaper Rash Cream

Diaper Rash Cream
SPL v1
SPL
SPL Set ID a6cb4d79-3276-a01d-6d5f-ef624cbeb016
Route
TOPICAL
Published
Effective Date 2011-02-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (15 g)
Inactive Ingredients
Yellow Wax Caprylyl Glycol Chamomile Citric Acid Monohydrate Ethylhexylglycerin Eucalyptus Oil Rosewood Oil Glycerin Lonicera Caprifolium Flower Hydrogenated Soybean Oil Lecithin, Soybean Panthenol Water Hyaluronate Sodium Sucrose Stearate Almond Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-12-20

Description

Zinc oxide 15.0%

Purpose

Diaper rash cream


Medication Information

Purpose

Diaper rash cream

Description

Zinc oxide 15.0%

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

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

Active Ingredient

Zinc oxide 15.0%

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

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

Uses
  • helps treat and prevent diaper rash

  • protects chafed skin due to diaper rash and helps seal out wetness

Purpose

Diaper rash cream

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

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

Active Ingredient

Zinc oxide 15.0%

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

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.


Advanced Ingredient Data


Raw Label Data

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