Label: NATURALS BY SAFETY 1ST- zinc oxide ointment
- NDC Code(s): 50428-3001-7, 50428-3001-8
- Packager: Dorel Juvenile Group
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated November 9, 2012
If you are a consumer or patient please visit this version.
- Active ingredient
Zinc Oxide 10%Close
- Helps improve the skin condition where diaper rash or redness is present.
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.Close
- 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.Close
- Principal Display Panel
naturals™ by Safety 1st® Diaper Rash Cream
Pediatrician tested · Naturally mild & effective
Developed with safety in mind
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
Made in CANADA
- INGREDIENTS AND APPEARANCE
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)