DIAPER RASH BALM- skin protectant ointment

Diaper Rash Balm by

Drug Labeling and Warnings

Diaper Rash Balm by is a Otc medication manufactured, distributed, or labeled by Skinfix, Inc., Product Integrity Laboratory, LLC, Canadian Custom Packaging Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Package Label Principal Display

Treats rash, redness & Irritation

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 . Avoid contact with eyes

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 and allow to dry.  Apply balm liberally as often as necessary, especially at bedtime or anytime when exposure to wet diapers may be prolonged.

ACTIVE INGREDIENT

PURPOSE

KEEP OUT OF REACH OF CHILDREN

INDICATIONS & USAGE

WARNINGS

DOSAGE & ADMINISTRATION

INACTIVE INGREDIENT

INGREDIENTS AND APPEARANCE

DIAPER RASH BALM 
skin protectant ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61328-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	0.2 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PETROLATUM (UNII: 4T6H12BN9U)
ALCOHOL (UNII: 3K9958V90M)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
JOJOBA OIL (UNII: 724GKU717M)
WHITE WAX (UNII: 7G1J5DA97F)
PARAFFIN (UNII: I9O0E3H2ZE)
ALLANTOIN (UNII: 344S277G0Z)
BENZOIN RESIN (UNII: GK21SBA74R)
LIQUIDAMBAR ORIENTALIS RESIN (UNII: 63V91G4W93)
TOLU BALSAM (UNII: TD2LE91MBE)
ALOE (UNII: V5VD430YW9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61328-001-01	60 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part347	12/09/2013

Labeler - Skinfix, Inc. (203158183)

Registrant - Product Integrity Laboratory, LLC (783863694)

Establishment
Name	Address	ID/FEI	Business Operations
Canadian Custom Packaging Company		207062514	manufacture(61328-001)