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Name:Naturals By Safety 1st
Manufacturer:Dorel Juvenile Group
Category:Over-the-counter (OTC) Marketed Drugs


Naturals™ by Safety 1st® Diaper Rash Cream

NATURALS BY SAFETY 1ST - zinc oxide ointment 
Dorel Juvenile Group

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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Naturals™ by Safety 1st® Diaper Rash Cream

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Uses

  • Helps improve the skin condition where diaper rash or redness is present.

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 within a few days

Keep out of reach of children

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

Directions

  • remove safety seal, do not use if broken
  • change wet and soiled diapers promptly
  • cleanse the diaper area, and 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 at 59° to 86° F (15° to 30° C)

Inactive ingredients

Water (Aqua), Canola Oil, Ricinus Communis (Castor) Seed Oil, Stearic Acid, Glycerin, Cetyl Alcohol, Beeswax, Cetearyl Glucoside, Benzyl Alcohol, Sodium Hydroxide, Lonicera Caprifoilum (Honeysuckle) Flower Extract, Lonicera Japanica (Honeysuckle) Flower Extract, Fragrance.

Principal Display Panel

naturals™ by Safety 1st® Diaper Rash Cream

Pediatrician tested · Naturally mild & effective

Developed with safety in mind

99.09% Natural

Bath time experts at Safety 1st worked with parents to develop a natural baby bath & body care line that you can count on to be Safety 1st safe & naturally effective.

  • No parabens, phthalates, formaldehyde or dyes
  • No harmful chemicals/preservatives

Manufactured for Dorel Juvenile Group.

©2010 Dorel Juvenile Group. All Rights Reserved.

2525 State Street, Columbus, IN 47201

www.djgusa.com (877)657-9545

www.safety1st.com/babycare

Made in CANADA

Principal Display Panel - Tube

Tube Label


NATURALS BY SAFETY 1ST 
zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50428-3001
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 8.8 g  in 88 mL
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50428-3001-8 6 TUBE ( TUBE) in 1 CARTON contains a TUBE (50428-3001-7)
1 NDC:50428-3001-7 88 mL in 1 TUBE This package is contained within the CARTON (50428-3001-8)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part347 02/01/2010

Labeler - Dorel Juvenile Group (118841501)

Revised: 02/2010 Dorel Juvenile Group



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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