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

Warnings:

For external use only.

When using this product

Stop use and ask a doctor if

Keep out of reach of children

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

Directions

Other information

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.

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 (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 8.8 g  in 88 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
CANOLA OIL (UNII: 331KBJ17RK)  
CASTOR OIL (UNII: D5340Y2I9G)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
LONICERA CAPRIFOLIUM FLOWER (UNII: 5N1WD9784U)  
LONICERA JAPONICA FLOWER (UNII: 4465L2WS4Y)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50428-3001-8 6 in 1 CARTON
1 NDC:50428-3001-7 88 mL in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 02/01/2010
Labeler - Dorel Juvenile Group (118841501)

Revised: 11/2012
Document Id: 51c10961-bcf8-49d1-9b56-4825290b319e
Set id: 183c6b92-33dd-4b45-8681-0e7af70015c0
Version: 2
Effective Time: 20121109
 
Dorel Juvenile Group