Creamy Diaper Rash: Package Insert and Label Information

CREAMY DIAPER RASH- zinc oxide ointment
Kroger Co.

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.

Active Ingredient

Zinc oxide 13%

Purpose

Skin protectant

uses

  • helps treat and prevent diaper rash
  • protects chafed skin due to diaper rash and helps seal out wetness

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

Stop use and ask a doctor if

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

Directions

  • change wet and soiled diapers promptly
  • cleanse the diaper area
  • allow to dry
  • apply ointment 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 between 20⁰ and 25⁰ C (68⁰ — 77⁰ F)

inactive ingredients

water, mineral oil, petrolatum, beeswax, dimethicone, sorbitan sesquioleate, microcrystalline wax, PEG-30 dipolyhydroxystearate, Aloe barbadensis leaf juice, glycerin, tropolone, tocopheryl acetate, 1,2-hexanediol, caprylyl glycol, magnesium sulfate, potassium hydroxide, phenoxyethanol

Adverse reaction

DISTRIBUTED BY THE KROGER CO.
CINCINNATI, OHIO 45202

226.002/226AD

principal display panel

COMFORTS FOR BABY

Skin Protectant

Creamy Diaper Rash Ointment

Aloe, Vitamin E, + Zinc Oxide

  • Seals out wetness
  • Hypoallergenic
  • Creamy formula
  • Fresh Scent

NET WT 4 OZ (113 g)

image description
(click image for full-size original)
CREAMY DIAPER RASH
zinc oxide ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:30142-226
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 13.0 kg in 100 kg
Inactive Ingredients
Ingredient Name Strength
WATER
MINERAL OIL
PETROLATUM
YELLOW WAX
DIMETHICONE
SORBITAN SESQUIOLEATE
MICROCRYSTALLINE WAX
PEG-30 DIPOLYHYDROXYSTEARATE
ALOE VERA LEAF
GLYCERIN
TROPOLONE
.ALPHA.-TOCOPHEROL ACETATE
1,2-HEXANEDIOL
CAPRYLYL GLYCOL
MAGNESIUM SULFATE MONOHYDRATE
POTASSIUM HYDROXIDE
PHENOXYETHANOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:30142-226-26 .113 kg in 1 TUBE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part347 06/19/1994
Labeler — Kroger Co. (006999528)
Registrant — Vi Jon, LLC (790752542)
Establishment
Name Address ID/FEI Operations
Vi Jon, LLC 790752542 manufacture (30142-226)

Revised: 04/2021 Kroger Co.

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