DIAPER RASH- zinc oxide paste

Diaper Rash by

Drug Labeling and Warnings

Diaper Rash by is a Otc medication manufactured, distributed, or labeled by Kroger Co, Vi Jon. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Zinc oxide  40%

Purpose

Skin protectant

Uses

helps treat and prevent diaper rash
protects chafed skin due to the 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

Keep out of reach of children.

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 25⁰C (68⁰ and 77⁰F)

Inactive ingredients

petrolatum, cod liver oil, lanolin, Zea mays (corn) starch, glycerin, sorbitan sesquioleate, beeswax, tocoperyl acetate, fragrance

Questions

1-855-200-BABY  www.ComfortsForBaby.com

Adverse reaction

DISTRIBUTED BY

THE KROGER CO.

CINCINNATI, OHIO 45202

020.002/020AC

principal display panel

NDC: 30142-020-26

COMFORTS

MAXIMUM STRENGTH

DIAPER RASH OINTMENT

PARABEN FREE

40% ZINC OXIDE - SKIN  PROTECTANT

• Helps Heal, Soothe & Prevent Diaper Rash
• Seals Out Wetness
• Hypoallergenic
• Gentle on Baby's Skin

NET WT 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

DIAPER RASH 
zinc oxide paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 30142-020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	532 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
COD LIVER OIL (UNII: BBL281NWFG)
LANOLIN (UNII: 7EV65EAW6H)
STARCH, CORN (UNII: O8232NY3SJ)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
YELLOW WAX (UNII: 2ZA36H0S2V)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 30142-020-26	1 in 1 CARTON	05/15/2009
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	05/15/2009

Labeler - Kroger Co (006999528)

Registrant - Vi Jon (790752542)

Establishment
Name	Address	ID/FEI	Business Operations
Vi Jon		790752542	manufacture(30142-020)