Medication Guide App

Naturals by Safety 1st

Dosage form: ointment
Ingredients: ZINC OXIDE 8.8g in 88mL
Labeler: Dorel Juvenile Group
NDC Code: 50428-3001

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.

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

Tube Label

NATURALS BY SAFETY 1ST 
zinc oxide ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50428-3001
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE8.8 g  in 88 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage Description
1NDC:50428-3001-86 TUBE in 1 CARTON
1NDC:50428-3001-788 mL in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34702/01/2010
Labeler - Dorel Juvenile Group (118841501)

Revised: 11/2012
 
Dorel Juvenile Group

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide
(web4)