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Naturals by Safety 1st

Dorel Juvenile Group

Naturals™ by Safety 1st® Diaper Rash Cream


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredient

Zinc Oxide 10%

Purpose

Skin Protectant

Naturals by Safety 1st 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

Naturals by Safety 1st 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

Naturals by Safety 1st
Tube Label

Naturals by Safety 1st

Zinc Oxide OINTMENT

Product Information

Product Type Human otc drug label 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 8.8 g

Inactive Ingredients

Ingredient Name Strength
water
CANOLA OIL
castor oil
STEARIC ACID
GLYCERIN
CETYL ALCOHOL
YELLOW WAX
CETEARYL GLUCOSIDE
BENZYL ALCOHOL
SODIUM HYDROXIDE
Lonicera Caprifolium Flower
LONICERA JAPONICA FLOWER

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50428-3001-7 88 in 1 TUBE
2 NDC:50428-3001-8 6 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part347 2010-02-01


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